This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | 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 |
| Notice Date | 1984-04-13 |
| PMA | P800043 |
| Supplement | S002 |
| Product Code | LKD |
| Advisory Committee | Anesthesiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RADIOMETER AMERICA, INC. 811 Sharon Dr. westlake, OH 44145 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800043 | Original Filing | |
| S004 | 1984-07-09 | |
| S003 | 1984-09-04 | |
| S002 | 1982-05-10 | |
| S001 | 1981-08-25 |