FDA 510(k) Applications Received During August, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K152404 08/25/2015 Hi-Torque Command 18 Guide Wire ABBOTT VASCULAR SHU CHI HSU
K152328 08/18/2015 FreeStyle InsuLinx Blood Glucose Monotioring System ABOTT LABORATORIES SAI SRIHARSHADA TATAVARTY
K152488 08/31/2015 Onrad Treatment System ACCURAY INCORPORATED ERIN DALY
K152379 08/21/2015 iHealth View BP7S Wireless Blood Pressure Wrist Monitor ANDON HEALTH CO.,LTD Liu Yi
K152346 08/20/2015 MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) BECKMAN COULTER, INC. SHANNON POPSON
K152208 08/07/2015 The Belmont Hyperthermia Pump BELMONT INSTRUMENT CORPORATION URAIWAN P LABADINI
K152437 08/27/2015 BiowaveHOME Neuromodulation Pain Therapy Device BIOWAVE CORPORATION BRADFORD SIFF
K152316 08/17/2015 iLab Ultrasound Imaging System BOSTON SCIENTIFIC George J Prendergast
K152403 08/25/2015 Permanent Sled Bag BOSTON SCIENTIFIC George J. Prendergast
K152286 08/13/2015 LigaSure Curved, Small Jaw, Open Sealer/Divider COVIDIEN DAWN TINDALL
K152407 08/25/2015 Infinity Delta, Infinity Delta XL, Infinity Kappa Draeger Medical Sytems, Inc. Beth Zis
K152383 08/24/2015 Ceramill Zolid FX Emergo Europe Consulting RACHEL PAUL
K152170 08/04/2015 Exactech Optetrak Logic Enhanced Assembly EXACTECH, INC. Patrick Hughes
K152408 08/25/2015 Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack FOCUS DIAGNOSTICS, INC. IRENE M GUZMAN
K152209 08/07/2015 FUJIFILM SonoSite X-Porte Ultrasound System FUJIFILM SONOSITE,INC. PATRICIA LIAU
K152303 08/14/2015 CT Sim Laser System GAMMEX, INC. Kenneth Windisch
K152195 08/05/2015 LOGIQ S8 GE Healthcare Bryan Behn
K152309 08/14/2015 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS BRYAN BEHN
K152483 08/31/2015 Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K152269 08/11/2015 Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC Jianqiu Fang
K152186 08/05/2015 HealthMyne PACS HEALTHMYNE, INC. SIGRID SCHOEPEL
K152207 08/06/2015 Extended Range Shifter for PROBEAT-V Hitachi,Ltd. , Health Care Company Naoya Nishimura
K152268 08/11/2015 VAPRO PLUS POCKET Intermittent Catheter HOLLISTER INCORPORATED JEANNE LEE
K152176 08/04/2015 Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation Joseph Ginete
K152158 08/03/2015 ARIX Ankle System Jeil Medical Corporation Jiwon KANG
K152281 08/12/2015 Pyrenees Cervical Plate System K2M Nancy Giezen
K152216 08/07/2015 SudoC LD TECHNOLOGY LLC Albert MAAREK
K152317 08/17/2015 Stretta Catheter MEDERI THERAPEUTICS INC. Oleg Shikhman
K152335 08/19/2015 Export Advance Aspiration Catheter Medtronic, Inc. Colleen Mullins
K152230 08/07/2015 Ebony PTA .014 RX Pheripheral Dilatation Catheter NATEC MEDICAL XAVIER DE BUCHERE
K152409 08/26/2015 Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC NAVILYST MEDICAL, INC. ROBIN FULLER
K152142 08/03/2015 RECON system - MPJ-Plates NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K152433 08/27/2015 VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 ORTHO CLINICAL DIAGNOSTICS Jessica Miller
K152171 08/04/2015 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 ORTHOFIX SRL GIANLUCA RICADONA
K152218 08/07/2015 AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System Osprey Medical Melanie Hess
K152220 08/07/2015 MH01 QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K152193 08/05/2015 Renovis Anterior Cervical Plate System Renovis Surgical Technologies, Inc. Anthony DeBenedictis
K152469 08/31/2015 ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION SHELLY PEARCE
K152250 08/10/2015 SpeqRT Signostics Limited Stewart Bartlett
K152143 08/03/2015 TRUCLEAR Operative Hysteroscope 5C and Sheath 5C SMITH & NEPHEW, INC. Bradley Heil
K152396 08/24/2015 S12 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152164 08/03/2015 S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152165 08/03/2015 S9 Portable Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152177 08/04/2015 SonoStik IV Guide Wire Introducer SONOSTIK, LLC RICHARD FOGEL
K152174 08/04/2015 Sniper Spine System SPINE WAVE, INC. Sanja Jahr
K152148 08/03/2015 Fortress Pedicular Fixation System SPINEOLOGY, INC. Karen Roche
K152190 08/05/2015 Thoratec CentriMag Drainage (Venous) Cannula Kit THORATEC CORPORATION Lori DonDiego
K152161 08/03/2015 Thoratec CentriMag Return (Arterial) Cannula Kit Thoratec Corporation Lori DonDiego
K152393 08/24/2015 Eclipse Treatment Planning System VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K152279 08/12/2015 ViZion DR + Wireless VIZTEK LLC BRUCE ASHBY
K152440 08/27/2015 Sydney IVF PVP WILLAM A. COOK AUSTRALIA PTY LTD GORDANA POZVEK
K152302 08/14/2015 Xenco Medical Cervical Interbody System (Argus) Xenco Medical, LLC Gustavo Prado


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