The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Model 7100 Comb. End Tidal Co2 & Pul Ox.
| Device ID | K920379 |
| 510k Number | K920379 |
| Device Name: | NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-29 |
| Decision Date | 1992-07-15 |