The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Marquette Compatible Sensors.
| Device ID | K010451 |
| 510k Number | K010451 |
| Device Name: | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS |
| Classification | Oximeter |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. Wallingford, CT 06492 |
| Contact | Robert H Schiffman, R.a.c. |
| Correspondent | Robert H Schiffman, R.a.c. NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. Wallingford, CT 06492 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-15 |
| Decision Date | 2001-04-25 |