The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Tcomette #809 Trans. Monitor.
| Device ID | K800988 |
| 510k Number | K800988 |
| Device Name: | NOVAMETRIX TCOMETTE #809 TRANS. MONITOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-24 |
| Decision Date | 1980-05-28 |