The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix 811 Transco2m Portable Transcutaneous 2.
| Device ID | K844253 |
| 510k Number | K844253 |
| Device Name: | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | Paul V Buday |
| Correspondent | Paul V Buday NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-02 |
| Decision Date | 1985-01-10 |