The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Transcutaneous O2/co2 Monitor.
| Device ID | K890517 |
| 510k Number | K890517 |
| Device Name: | TRANSCUTANEOUS O2/CO2 MONITOR |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Robert H Schiffman |
| Correspondent | Robert H Schiffman NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-04-14 |