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 | TCO2M MODEL 818 MONITOR |
| Generic Name | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| Date Received | 1986-03-31 |
| Decision Date | 1986-06-05 |
| PMA | P810022 |
| Supplement | S012 |
| Product Code | LKD |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 Barnes Industrial Park Rd. p.o. Box 690 wallingford, CT 06492 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810022 | Original Filing | |
| S014 | 1987-03-03 | Normal 180 Day Track |
| S013 | 1986-11-03 | Normal 180 Day Track |
| S012 | 1986-03-31 | Normal 180 Day Track |
| S011 | 1985-07-12 | |
| S010 | 1985-05-06 | |
| S009 | 1985-02-19 | |
| S008 | 1985-01-07 | |
| S007 | 1984-10-19 | |
| S006 | 1984-06-18 | |
| S005 | 1984-06-04 | |
| S004 | 1984-03-30 | |
| S003 | 1984-03-02 | |
| S002 | ||
| S001 | 1981-08-06 |