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.
Recent Cleared Devices (20 of 62)
Showing 20 most recent of 62 cleared devices.
| 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 |
Top Applicants
- Armour Pharmaceutical Co. — 5 clearances
- Monaghan Medical Corp. — 3 clearances
- Vortran Medical Technology 1, Inc. — 3 clearances
- Devilbiss Health Care, Inc. — 2 clearances
- Dey Laboratories, Inc. — 2 clearances
