Panels › Anesthesiology › Product code CCQ · Class 1
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Regulation 868.5640
0510(k)s in 12 months (62 all time)
0recalls in 12 months (9 all time)
2recalls that name a 510(k)
Top companies in CCQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Armour Pharmaceutical Co. | 5 | 0 |
| Teleflex Medical | 0 | 5 |
| Monaghan Medical Corp. | 3 | 0 |
| Nephron Pharmaceuticals Corp. | 0 | 3 |
| Vortran Medical Technology 1, Inc. | 3 | 0 |
| The Devilbiss Co. | 2 | 0 |
| Devilbiss Health Care, Inc. | 2 | 0 |
| Dey Laboratories, Inc. | 2 | 0 |
| Dhd Medical Products Div. Diemolding Corp. | 2 | 0 |
| Key Pharmaceuticals, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 1997 | K972397 | EZ SPRAY Intertex Research, Inc. | CCQ |
| Apr 23, 1997 | K964956 | E-Z SPACER MASK (SMALL) Airpharma, LLC | CCQ |
| Aug 14, 1996 | K961894 | MDI TUTOR Mdi Tutor, Inc. | CCQ |
| Jul 25, 1996 | K961455 | MEDSHIELD/AEROCHAMBER Diemolding Corp. | CCQ |
| May 10, 1996 | K960593 | SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 Aradigm Corp. | CCQ |
| Jul 21, 1992 | K922033 | SALINE SOLUTION- STERILE Trinity Laboratories, Inc. | CCQ |
| May 13, 1991 | K900576 | MODIFIED AEROCHAMBER WITH MASK Monaghan Medical Corp. | CCQ |
| Apr 10, 1991 | K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER Monaghan Medical Corp. | CCQ |
| May 18, 1990 | K895115 | FRANK INHALER THERMAL S Buttner-Frank GmbH, DE | CCQ |
| Apr 16, 1990 | K894215 | EVOLUTION ULTRASONIC Medical Industries America, Inc. | CCQ |
| Jan 24, 1990 | K894555 | PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED Dura Pharmaceuticals, Inc. | CCQ |
| Jan 17, 1990 | K896070 | PFEIFFER METERED DOSAGE SYSTEM Syva Co. | CCQ |
| Nov 21, 1989 | K895592 | FREEWAY NEBULIZER COMPRESSOR Lifecare Services, Inc. | CCQ |
| Oct 13, 1989 | K894441 | DEVILBISS MODEL 6610D Devilbiss Health Care, Inc. | CCQ |
| Oct 6, 1989 | K894244 | DEVILBISS MODEL 8500D AND 8500D-608 Devilbiss Health Care, Inc. | CCQ |
| Jun 23, 1989 | K892117 | GENTLEHALER(R) Schering Research | CCQ |
| Jan 22, 1988 | K875024 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP Dey Laboratories, Inc. | CCQ |
| Jan 22, 1988 | K875011 | DEY-PAK PURIFIED WATER, USP, STERILE Dey Laboratories, Inc. | CCQ |
| Dec 30, 1987 | K874513 | MONAGHAN AEROCHAMBER WITH MASK Monaghan Medical Corp. | CCQ |
| Oct 13, 1987 | K873793 | INSPIREASE(R), DRUG DELIVERY SYSTEM Key Pharmaceuticals, Inc. | CCQ |
| Oct 9, 1987 | K873477 | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) Vortran Medical Technology 1, Inc. | CCQ |
| Sep 11, 1987 | K872315 | MISTMASTER Sonora Respiratory Products, Inc. | CCQ |
| May 15, 1987 | K871151 | THE SPIRA ELEKTRO 2 Warren E. Collins, Inc. | CCQ |
| Apr 1, 1987 | K870332 | PREFILLED RESPIRATORY THERAPY VIALS Automatic Liquid Packaging, Inc. | CCQ |
| Mar 16, 1987 | K870755 | CHALLENGER DOSIMETER Salter Labs | CCQ |
| Mar 16, 1987 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER Salter Labs | CCQ |
| Mar 27, 1986 | K860800 | ROSENTHAL-FRENCH NEBULIZATION DOSIMETER Laboratory For Applied Immunology, Inc. | CCQ |
| Mar 20, 1986 | K860875 | CIRRUS DRUG NEBULIZER MK III Dhd Medical Products Div. Diemolding Corp. | CCQ |
| Jan 28, 1986 | K854952 | CIRRUS NEBULIZER-DELUXE KIT Dhd Medical Products Div. Diemolding Corp. | CCQ |
| Dec 19, 1985 | K854551 | MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S Medipart Jerry Alexander | CCQ |
| Dec 19, 1985 | K854550 | MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA Medipart Jerry Alexander | CCQ |
| Dec 9, 1985 | K854520 | PULMO-AIDE MODEL 5610D The Devilbiss Co. | CCQ |
| Sep 26, 1985 | K852627 | MAXI-NEB Ashai Co. , Ltd., AU | CCQ |
| Aug 29, 1985 | K853350 | SYNCHRONER TM (PROPOSED TRADENAME) Fisons Corp. | CCQ |
| Aug 29, 1985 | K853071 | MEDIX ELECTRONIC NEBULIZING SYSTEM Medix Corp., GB | CCQ |
| Aug 8, 1985 | K851525 | PFEIFFER PUMP Ing. Erich Pfeiffer GmbH & Co. Kg., DE | CCQ |
| Jun 18, 1985 | K851254 | MICRO-INHALER MODEL TV-7000 & TV-8000 Bioclimatic, Inc. | CCQ |
| May 23, 1985 | K850926 | MICRON ONE PORTA. ULTRASONIC NEBULIZER Endotek Development Laboratories | CCQ |
| Dec 13, 1984 | K844591 | MIST-EASE NEBULIZER General Physiotherapy, Inc. | CCQ |
| Aug 17, 1984 | K843102 | AVA-NEB NEBULIZER Avatron, Inc. | CCQ |
| Aug 7, 1984 | K842988 | VMT GENTLE-HALER Vortran Medical Technology 1, Inc. | CCQ |
| Jul 27, 1984 | K841991 | ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS Armour Pharmaceutical Co. | CCQ |
| Jul 27, 1984 | K841990 | ARM-A-CARE NEBULIZER-NEBULIZER Armour Pharmaceutical Co. | CCQ |
| Jul 27, 1984 | K841989 | ARM-A-VIAL LV SODIUM CHLORIDE INHALAT Armour Pharmaceutical Co. | CCQ |
| Jul 27, 1984 | K841988 | ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT Armour Pharmaceutical Co. | CCQ |
| Jul 27, 1984 | K841987 | ARM-A-VIAL LV STERIAL WATER FOR INHALA Armour Pharmaceutical Co. | CCQ |
| Jun 25, 1984 | K842192 | CROUP TENT FRAME Home Run Treadmill Co. | CCQ |
| Jun 5, 1984 | K841894 | VMT HAND HELD NEBULIZER Vortran Medical Technology 1, Inc. | CCQ |
| Apr 24, 1984 | K841469 | MISTY OX DISPOS. NEBULIZER Medical Molding Corp. of America | CCQ |
| Apr 13, 1984 | K841321 | AIR-NEB NEBULIZER COMPRESSOR UNIT Airmed Corp. | CCQ |
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