FDA 510(k) Applications for Medical Device Product Code "CCQ"
(Nebulizer, Medicinal, Non-Ventilatory (Atomizer))

FDA 510(k) Number Applicant Device Name Decision Date
K823423 ADVANCED TECHNOLOGY PRODUCTS, INC. NEBULIZER CHRONOLOG & INTERPRETER 12/15/1982
K841321 AIRMED CORP. AIR-NEB NEBULIZER COMPRESSOR UNIT 04/13/1984
K964956 AIRPHARMA, LLC E-Z SPACER MASK (SMALL) 04/23/1997
K960593 ARADIGM CORP. SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 05/10/1996
K841991 ARMOUR PHARMACEUTICAL CO. ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS 07/27/1984
K841990 ARMOUR PHARMACEUTICAL CO. ARM-A-CARE NEBULIZER-NEBULIZER 07/27/1984
K841989 ARMOUR PHARMACEUTICAL CO. ARM-A-VIAL LV SODIUM CHLORIDE INHALAT 07/27/1984
K841988 ARMOUR PHARMACEUTICAL CO. ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT 07/27/1984
K841987 ARMOUR PHARMACEUTICAL CO. ARM-A-VIAL LV STERIAL WATER FOR INHALA 07/27/1984
K852627 ASHAI CO. LTD. MAXI-NEB 09/26/1985
K870332 AUTOMATIC LIQUID PACKAGING, INC. PREFILLED RESPIRATORY THERAPY VIALS 04/01/1987
K843102 AVATRON, INC. AVA-NEB NEBULIZER 08/17/1984
K811404 B & F MEDICAL PRODUCTS, INC. TRAVELAIRE 06/09/1981
K851254 BIOCLIMATIC, INC. MICRO-INHALER MODEL TV-7000 & TV-8000 06/18/1985
K895115 BUTTNER-FRANK GMBH FRANK INHALER THERMAL S 05/18/1990
K894441 DEVILBISS HEALTH CARE, INC. DEVILBISS MODEL 6610D 10/13/1989
K894244 DEVILBISS HEALTH CARE, INC. DEVILBISS MODEL 8500D AND 8500D-608 10/06/1989
K875024 DEY LABORATORIES, INC. DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP 01/22/1988
K875011 DEY LABORATORIES, INC. DEY-PAK PURIFIED WATER, USP, STERILE 01/22/1988
K860875 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. CIRRUS DRUG NEBULIZER MK III 03/20/1986
K854952 DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. CIRRUS NEBULIZER-DELUXE KIT 01/28/1986
K961455 DIEMOLDING CORP. MEDSHIELD/AEROCHAMBER 07/25/1996
K894555 DURA PHARMACEUTICALS, INC. PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED 01/24/1990
K850926 ENDOTEK DEVELOPMENT LABORATORIES MICRON ONE PORTA. ULTRASONIC NEBULIZER 05/23/1985
K853350 FISONS CORP. SYNCHRONER TM (PROPOSED TRADENAME) 08/29/1985
K844591 GENERAL PHYSIOTHERAPY, INC. MIST-EASE NEBULIZER 12/13/1984
K842192 HOME RUN TREADMILL CO. CROUP TENT FRAME 06/25/1984
K851525 ING. ERICH PFEIFFER GMBH & CO. KG. PFEIFFER PUMP 08/08/1985
K781394 INHAL-O-TECH MEDICAL PLASTIC DISPOSABLE INCENTIVE SPIROMETER 10/16/1978
K972397 INTERTEX RESEARCH, INC. EZ SPRAY 09/23/1997
K832037 KEY PHARMACEUTICALS, INC. INSPIREASE 08/16/1983
K873793 KEY PHARMACEUTICALS, INC. INSPIREASE(R), DRUG DELIVERY SYSTEM 10/13/1987
K860800 LABORATORY FOR APPLIED IMMUNOLOGY, INC. ROSENTHAL-FRENCH NEBULIZATION DOSIMETER 03/27/1986
K895592 LIFECARE SERVICES, INC. FREEWAY NEBULIZER COMPRESSOR 11/21/1989
K961894 MDI TUTOR, INC. MDI TUTOR 08/14/1996
K894215 MEDICAL INDUSTRIES AMERICA, INC. EVOLUTION ULTRASONIC 04/16/1990
K841469 MEDICAL MOLDING CORP. OF AMERICA MISTY OX DISPOS. NEBULIZER 04/24/1984
K854551 MEDIPART JERRY ALEXANDER MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S 12/19/1985
K854550 MEDIPART JERRY ALEXANDER MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA 12/19/1985
K853071 MEDIX CORP. MEDIX ELECTRONIC NEBULIZING SYSTEM 08/29/1985
K900557 MONAGHAN MEDICAL CORP. MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER 04/10/1991
K900576 MONAGHAN MEDICAL CORP. MODIFIED AEROCHAMBER WITH MASK 05/13/1991
K874513 MONAGHAN MEDICAL CORP. MONAGHAN AEROCHAMBER WITH MASK 12/30/1987
K760580 OHIO MEDICAL PRODUCTS DRUG NEBULIZER 09/21/1976
K812503 RETLIF, INC. BOSCH HEARING INSTRUMENTS 09/24/1981
K870755 SALTER LABS CHALLENGER DOSIMETER 03/16/1987
K870027 SALTER LABS HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER 03/16/1987
K892117 SCHERING RESEARCH GENTLEHALER(R) 06/23/1989
K802281 SHERWOOD MEDICAL CO. SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC 10/03/1980
K872315 SONORA RESPIRATORY PRODUCTS, INC. MISTMASTER 09/11/1987
K896070 SYVA CO. PFEIFFER METERED DOSAGE SYSTEM 01/17/1990
K854520 THE DEVILBISS CO. PULMO-AIDE MODEL 5610D 12/09/1985
K781073 THE DEVILBISS CO. PULMO-SONIC 09/27/1978
K810343 TODD INDUSTRIES, INC. NEBULIZERS 03/17/1981
K922033 TRINITY LABORATORIES, INC. SALINE SOLUTION- STERILE 07/21/1992
K833474 VIRAL RESPONSE SYSTEM, INC. VIRALIZER NEBULIZER SPRAYER 12/27/1983
K800763 VIX BREATHING EQUIPMENT CO. MISER INHALATION DEVICE, PART NO. 700 04/24/1980
K873477 VORTRAN MEDICAL TECHNOLOGY 1, INC. INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) 10/09/1987
K842988 VORTRAN MEDICAL TECHNOLOGY 1, INC. VMT GENTLE-HALER 08/07/1984
K841894 VORTRAN MEDICAL TECHNOLOGY 1, INC. VMT HAND HELD NEBULIZER 06/05/1984
K871151 WARREN E. COLLINS, INC. THE SPIRA ELEKTRO 2 05/15/1987


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