CCQ · Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Anesthesiology · 21 CFR 868.5640 · Class 1
Overview
| Product Code | CCQ |
|---|---|
| Device Name | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) |
| Regulation | 21 CFR 868.5640 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
Cleared Devices (62)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972397 | EZ SPRAY | Intertex Research, Inc. | Sep 23, 1997 | SESE |
| K964956 | E-Z SPACER MASK (SMALL) | Airpharma, LLC | Apr 23, 1997 | SESE |
| K961894 | MDI TUTOR | Mdi Tutor, Inc. | Aug 14, 1996 | SESE |
| K961455 | MEDSHIELD/AEROCHAMBER | Diemolding Corp. | Jul 25, 1996 | SESE |
| K960593 | SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 | Aradigm Corp. | May 10, 1996 | SESE |
| K922033 | SALINE SOLUTION- STERILE | Trinity Laboratories, Inc. | Jul 21, 1992 | SESE |
| K900576 | MODIFIED AEROCHAMBER WITH MASK | Monaghan Medical Corp. | May 13, 1991 | SESE |
| K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER | Monaghan Medical Corp. | Apr 10, 1991 | SESE |
| K895115 | FRANK INHALER THERMAL S | Buttner-Frank GmbH | May 18, 1990 | SESE |
| K894215 | EVOLUTION ULTRASONIC | Medical Industries America, Inc. | Apr 16, 1990 | SESE |
| K894555 | PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED | Dura Pharmaceuticals, Inc. | Jan 24, 1990 | SESE |
| K896070 | PFEIFFER METERED DOSAGE SYSTEM | Syva Co. | Jan 17, 1990 | SESE |
| K895592 | FREEWAY NEBULIZER COMPRESSOR | Lifecare Services, Inc. | Nov 21, 1989 | SESE |
| K894441 | DEVILBISS MODEL 6610D | Devilbiss Health Care, Inc. | Oct 13, 1989 | SESE |
| K894244 | DEVILBISS MODEL 8500D AND 8500D-608 | Devilbiss Health Care, Inc. | Oct 6, 1989 | SESE |
| K892117 | GENTLEHALER(R) | Schering Research | Jun 23, 1989 | SESE |
| K875024 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP | Dey Laboratories, Inc. | Jan 22, 1988 | SESE |
| K875011 | DEY-PAK PURIFIED WATER, USP, STERILE | Dey Laboratories, Inc. | Jan 22, 1988 | SESE |
| K874513 | MONAGHAN AEROCHAMBER WITH MASK | Monaghan Medical Corp. | Dec 30, 1987 | SESE |
| K873793 | INSPIREASE(R), DRUG DELIVERY SYSTEM | Key Pharmaceuticals, Inc. | Oct 13, 1987 | SESE |
| K873477 | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) | Vortran Medical Technology 1, Inc. | Oct 9, 1987 | SESE |
| K872315 | MISTMASTER | Sonora Respiratory Products, Inc. | Sep 11, 1987 | SESE |
| K871151 | THE SPIRA ELEKTRO 2 | Warren E. Collins, Inc. | May 15, 1987 | SESE |
| K870332 | PREFILLED RESPIRATORY THERAPY VIALS | Automatic Liquid Packaging, Inc. | Apr 1, 1987 | SESE |
| K870755 | CHALLENGER DOSIMETER | Salter Labs | Mar 16, 1987 | SESE |
| K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | Salter Labs | Mar 16, 1987 | SESE |
| K860800 | ROSENTHAL-FRENCH NEBULIZATION DOSIMETER | Laboratory For Applied Immunology, Inc. | Mar 27, 1986 | SESE |
| K860875 | CIRRUS DRUG NEBULIZER MK III | Dhd Medical Products Div. Diemolding Corp. | Mar 20, 1986 | SESE |
| K854952 | CIRRUS NEBULIZER-DELUXE KIT | Dhd Medical Products Div. Diemolding Corp. | Jan 28, 1986 | SESE |
| K854551 | MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S | Medipart Jerry Alexander | Dec 19, 1985 | SESE |
| K854550 | MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA | Medipart Jerry Alexander | Dec 19, 1985 | SESE |
| K854520 | PULMO-AIDE MODEL 5610D | The Devilbiss Co. | Dec 9, 1985 | SESE |
| K852627 | MAXI-NEB | Ashai Co. , Ltd. | Sep 26, 1985 | SESE |
| K853350 | SYNCHRONER TM (PROPOSED TRADENAME) | Fisons Corp. | Aug 29, 1985 | SESE |
| K853071 | MEDIX ELECTRONIC NEBULIZING SYSTEM | Medix Corp. | Aug 29, 1985 | SESE |
| K851525 | PFEIFFER PUMP | Ing. Erich Pfeiffer GmbH & Co. Kg. | Aug 8, 1985 | SESE |
| K851254 | MICRO-INHALER MODEL TV-7000 & TV-8000 | Bioclimatic, Inc. | Jun 18, 1985 | SESE |
| K850926 | MICRON ONE PORTA. ULTRASONIC NEBULIZER | Endotek Development Laboratories | May 23, 1985 | SESE |
| K844591 | MIST-EASE NEBULIZER | General Physiotherapy, Inc. | Dec 13, 1984 | SESE |
| K843102 | AVA-NEB NEBULIZER | Avatron, Inc. | Aug 17, 1984 | SESE |
| K842988 | VMT GENTLE-HALER | Vortran Medical Technology 1, Inc. | Aug 7, 1984 | SESE |
| K841991 | ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS | Armour Pharmaceutical Co. | Jul 27, 1984 | SESE |
| K841990 | ARM-A-CARE NEBULIZER-NEBULIZER | Armour Pharmaceutical Co. | Jul 27, 1984 | SESE |
| K841989 | ARM-A-VIAL LV SODIUM CHLORIDE INHALAT | Armour Pharmaceutical Co. | Jul 27, 1984 | SESE |
| K841988 | ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT | Armour Pharmaceutical Co. | Jul 27, 1984 | SESE |
| K841987 | ARM-A-VIAL LV STERIAL WATER FOR INHALA | Armour Pharmaceutical Co. | Jul 27, 1984 | SESE |
| K842192 | CROUP TENT FRAME | Home Run Treadmill Co. | Jun 25, 1984 | SESE |
| K841894 | VMT HAND HELD NEBULIZER | Vortran Medical Technology 1, Inc. | Jun 5, 1984 | SESE |
| K841469 | MISTY OX DISPOS. NEBULIZER | Medical Molding Corp. of America | Apr 24, 1984 | SESE |
| K841321 | AIR-NEB NEBULIZER COMPRESSOR UNIT | Airmed Corp. | Apr 13, 1984 | SESE |
| K833474 | VIRALIZER NEBULIZER SPRAYER | Viral Response System, Inc. | Dec 27, 1983 | SESE |
| K832037 | INSPIREASE | Key Pharmaceuticals, Inc. | Aug 16, 1983 | SESE |
| K823423 | NEBULIZER CHRONOLOG & INTERPRETER | Advanced Technology Products, Inc. | Dec 15, 1982 | SESE |
| K822625 | SYNTEVENT ATOMIZER/NEBULIZER AEROSOL | Syva Co. | Oct 13, 1982 | SESE |
| K812503 | BOSCH HEARING INSTRUMENTS | Retlif, Inc. | Sep 24, 1981 | SESE |
| K811404 | TRAVELAIRE | B & F Medical Products, Inc. | Jun 9, 1981 | SESE |
| K810343 | NEBULIZERS | Todd Industries, Inc. | Mar 17, 1981 | SESE |
| K802281 | SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC | Sherwood Medical Co. | Oct 3, 1980 | SESE |
| K800763 | MISER INHALATION DEVICE, PART NO. 700 | Vix Breathing Equipment Co. | Apr 24, 1980 | SESE |
| K781394 | DISPOSABLE INCENTIVE SPIROMETER | Inhal-O-Tech Medical Plastic | Oct 16, 1978 | SESE |
| K781073 | PULMO-SONIC | The Devilbiss Co. | Sep 27, 1978 | SESE |
| K760580 | DRUG NEBULIZER | Ohio Medical Products | Sep 21, 1976 | SESE |
Top Applicants
- Armour Pharmaceutical Co. — 5 clearances
- Vortran Medical Technology 1, Inc. — 3 clearances
- Monaghan Medical Corp. — 3 clearances
- The Devilbiss Co. — 2 clearances
- Syva Co. — 2 clearances
