FDA 510(k) Applications for Medical Device Product Code "DPT"
(Probe, Blood-Flow, Extravascular)

FDA 510(k) Number Applicant Device Name Decision Date
K874861 ACUSON COMPUTED SONOGRAPHY ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. 05/11/1988
K910441 ADVANCE MEDICAL DEVICE, INC. FLOSCOPE MICRODOP 03/21/1991
K872441 ADVANCED TECHNOLOGY LABORATORIES, INC. HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR 02/19/1988
K121429 AIMAGO SA AIMAGO EASYLDI MICROCIRCULATION CAMERA 08/10/2012
K123216 AIMAGO SA AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN 02/07/2013
K830858 BIO MEDICUS, INC. BIO-PROBE SYSTEM-BLOOD FLOW PROBE 06/08/1983
K792015 D. E. HOKANSON, INC. P-2 ULTRASONIC ARTERIOGRAPH 12/04/1979
K874138 DATASCOPE CORP. ACCUCOM 2 06/01/1988
K052989 DELTEX MEDICAL DP240 240 HOUR DOPPLER PROBE 03/08/2006
K142932 DELTEX MEDICAL LIMITED Deltex Medical KDP72 Doppler Probe 01/22/2015
K073593 DELTEX MEDICAL LIMITED I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 01/29/2009
K902977 DONALD L. KING M.D. K3 COMPUTER SYSTEMS 04/28/1992
K871912 ELECTRO-DIAGNOSTIC INSTRUMENTS PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM 02/18/1988
K873214 GENERAL ELECTRIC CO. APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300 06/01/1988
K896435 HEWLETT-PACKARD CO. HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM 02/07/1990
K905728 HEWLETT-PACKARD CO. SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM 03/15/1991
K912404 HEWLETT-PACKARD CO. TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY 11/07/1991
K963703 INTERNATIONAL BIOPHYSICS CORP. ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) 04/08/1998
K863372 INTERSPEC, INC. SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES 11/04/1986
K013939 JOSTRA AG JOSTRA FLOWPROBE FP-32E 12/14/2001
K896437 KONTRON INSTRUMENTS, INC. KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM 12/03/1990
K873041 LIFE SCIENCES MANUFACTURING, INC. A-V RECORDER 02/04/1988
K942377 MEDEX, INC. TRANSTAR PRESSURE TRANSDUCER 08/16/1994
K924208 MEDTRONIC BIO-MEDICUS, INC. BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P) 07/08/1993
K132730 MEDTRONIC INC. BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE 05/30/2014
K133903 MEDTRONIC INC. BIO-PROBE TRANSDUCER (ADULT) 04/10/2014
K012747 MEDTRONIC PERFUSION SYSTEMS TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) 09/14/2001
K152749 Moor Instruments Ltd moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager 05/12/2016
K980383 MOOR INSTRUMENTS LTD. MOOORLDI LASER DOPPLER IMAGER 04/30/1998
K063586 MOOR INSTRUMENTS LTD. MOORFLPI FULL-FIELD LASER PERFUSION IMAGER 01/25/2007
K122943 MOOR INSTRUMENTS LTD. MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER 01/03/2013
K060976 MOOR INSTRUMENTS LTD. MOORLD12-B1 LASER DOPPLER BURNS IMAGER 03/27/2007
K032841 MOOR INSTRUMENTS LTD. MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR 12/10/2003
K063561 MOOR INSTRUMENTS LTD. MOORLDLS LASER DOPPLER LINE SCANNER 01/19/2007
K132163 MOOR INSTRUMENTS LTD. MOORLDLS-BI LASER DOPPLER BURNS IMAGER 01/29/2014
K860435 MULTIGON INDUSTRIES, INC. MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER 05/05/1986
K860121 NUMED, INC. INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER 06/02/1986
K120884 PERIMED AB PERICAM PSI 07/03/2012
K873673 SONICAID, INC. BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL 02/26/1988
K124049 Spectral MD, Inc DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM 04/18/2013
K163339 SPECTRALMD, INC. SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 08/17/2017
K875266 TOSHIBA MEDICAL SYSTEMS SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM 04/29/1988
K881303 TRITON TECHNOLOGY, INC. TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER 11/29/1988
K951832 VASAMEDICS, L.L.C. LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433 03/21/1996
K961368 VASAMEDICS, L.L.C. TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT 10/11/1996
K962700 VASAMEDICS, L.L.C. VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT 04/09/1997
K781413 VITALAB PRODUCTS CORP. MASK, PXYGEN 09/07/1978


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