PZ-800 VOLUME VENTILATOR
FDA 510(k) clearance K822835 · decided 1983-09-29
Clearance details
- K-number
- K822835
- Device name
- PZ-800 VOLUME VENTILATOR
- Applicant
- Narco Scientific
- Decision
- Substantially Equivalent
- Date received
- 1982-09-21
- Decision date
- 1983-09-29
- Days to decision
- 373 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TCPCO2 MONITORING SYSTEM (P820025/S001) | Narco Scientific | 1984-04-18 |
| JAUNDICE METER 101 (P810007) | Narco Scientific | 1981-11-20 |