FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE NEBULIZER
K Number: K761299
·
Decision Dec 30, 1976
Classifications
1
FEI Numbers
187
Registration Numbers
188
Same Product Code
503
Applicant Total
8
Review Days
9
Basic Information
- Device Name
- DISPOSABLE NEBULIZER
- K Number
- K761299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- MCGAW RESPIRATORY THERAPY
- Date Received
- December 21, 1976
- Decision Date
- December 30, 1976
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by MCGAW RESPIRATORY THERAPY
| K Number | Device Name | ||
|---|---|---|---|
| K771550 | MRT DISPENSOR | Sep 20, 1977 | Substantially Equivalent |
| K771516 | CAPILLARY SAMPLE LINE | Aug 16, 1977 | Substantially Equivalent |
| K770665 | VALVE, PRESSURE, DEMAND | Apr 15, 1977 | Substantially Equivalent |
| K770286 | VENTILATOR BREATHING CIRCUIT | Feb 25, 1977 | Substantially Equivalent |
| K761300 | NEBULIZER CONTROL UNIT | Dec 30, 1976 | Substantially Equivalent |
| K761298 | PRE-FILLED DISPOSABLE NEBULIZER | Dec 30, 1976 | Substantially Equivalent |
| K760998 | ENDOTRACHAEL TUBE AND HOLDER | Nov 19, 1976 | Substantially Equivalent |