MIST-EASE NEBULIZER
FDA 510(k) clearance K844591 · decided 1984-12-13
Clearance details
- K-number
- K844591
- Device name
- MIST-EASE NEBULIZER
- Applicant
- General Physiotherapy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-11-26
- Decision date
- 1984-12-13
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- CCQ
- Device class
- 1
- Regulation number
- 868.5640
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EZ SPRAY (K972397) | Intertex Research, Inc. | 1997-09-23 |
| E-Z SPACER MASK (SMALL) (K964956) | Airpharma, LLC | 1997-04-23 |
| MDI TUTOR (K961894) | Mdi Tutor, Inc. | 1996-08-14 |
| MEDSHIELD/AEROCHAMBER (K961455) | Diemolding Corp. | 1996-07-25 |
| SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 (K960593) | Aradigm Corp. | 1996-05-10 |
| SALINE SOLUTION- STERILE (K922033) | Trinity Laboratories, Inc. | 1992-07-21 |
| MODIFIED AEROCHAMBER WITH MASK (K900576) | Monaghan Medical Corp. | 1991-05-13 |
| MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (K900557) | Monaghan Medical Corp. | 1991-04-10 |
| FRANK INHALER THERMAL S (K895115) | Buttner-Frank GmbH | 1990-05-18 |
| EVOLUTION ULTRASONIC (K894215) | Medical Industries America, Inc. | 1990-04-16 |
| PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED (K894555) | Dura Pharmaceuticals, Inc. | 1990-01-24 |
| PFEIFFER METERED DOSAGE SYSTEM (K896070) | Syva Co. | 1990-01-17 |
Recalls involving this device
No recalls on record reference this clearance.