LITTON TRANSCUTANEOUS CO2 SYSTEM
FDA premarket approval P850087/S001 · decided 1986-11-14
Approval details
- PMA number
- P850087
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- LITTON TRANSCUTANEOUS CO2 SYSTEM
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Litton Datamedix
- Date received
- 1986-09-12
- Decision date
- 1986-11-14
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Sharon, MA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI (K853599) | Litton Datamedix | 1986-03-21 |
| ULTRASOUND GEL (K850290) | Litton Datamedix | 1985-04-18 |
| SERVOMED OXYMONITO SMK 363 (K842497) | Litton Datamedix | 1984-10-04 |
| SERVOCARD DEFIBRILLATOR SCP-851 (K842235) | Litton Datamedix | 1984-08-27 |
| SERVOCARD SCP-840 (K842312) | Litton Datamedix | 1984-08-27 |