TCPCO2 MONITORING SYSTEM
FDA premarket approval P820025/S001 · decided 1984-04-18
Approval details
- PMA number
- P820025
- Supplement
- S001
- Trade name
- TCPCO2 MONITORING SYSTEM
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Narco Scientific
- Date received
- 1984-01-11
- Decision date
- 1984-04-18
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatboro, PA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NARCOTRACE 80 (K830338) | Narco Scientific | 1983-12-22 |
| AS 191 ECG TELEMETRY MODULE (K831429) | Narco Scientific | 1983-10-14 |
| AS 1740 INTERFACE MODULE (K831428) | Narco Scientific | 1983-10-14 |
| PZ-800 VOLUME VENTILATOR (K822835) | Narco Scientific | 1983-09-29 |
| AIR SHIELDS AS-100 MONIORING SYS-AS105 (K831430) | Narco Scientific | 1983-09-12 |
| AS 30/TCP MODULE (K831460) | Narco Scientific | 1983-07-12 |
| DISP. YANKAVER SURG. SUCTION INSTRUMENT (K830123) | Narco Scientific | 1983-06-08 |
| TI-1000 TRANSPORT INCUBATOR (K831028) | Narco Scientific | 1983-05-09 |