RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
FDA premarket approval P800043/S002 · decided 1984-03-01
Approval details
- PMA number
- P800043
- Supplement
- S002
- Trade name
- RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
- Generic name
- MONITOR, CARBON-DIOXIDE, CUTANEOUS
- Applicant
- Radiometer America, Inc.
- Date received
- 1982-05-10
- Decision date
- 1984-03-01
- Days to decision
- 661 days
- Decision code
- APPR
- Product code
- LKD
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Westlake, OH
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit (K153712) | Radiometer America, Inc. | 2016-01-28 |
| ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (K992859) | Radiometer America, Inc. | 2000-01-10 |
| ABL 735 ANALYZER (K991417) | Radiometer America, Inc. | 1999-11-24 |
| NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (K982928) | Radiometer America, Inc. | 1999-01-06 |
| ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130) | Radiometer America, Inc. | 1998-02-09 |
| QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (K980135) | Radiometer America, Inc. | 1998-01-28 |
| ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K974818) | Radiometer America, Inc. | 1998-01-16 |
| ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K973367) | Radiometer America, Inc. | 1997-10-06 |