The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Modification To Marspo2, Model 2001.
| Device ID | K000794 |
| 510k Number | K000794 |
| Device Name: | MODIFICATION TO MARSPO2, MODEL 2001 |
| Classification | Oximeter |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. Wallingford, CT 06492 |
| Contact | Robert H Schiffman |
| Correspondent | Robert H Schiffman NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. Wallingford, CT 06492 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-13 |
| Decision Date | 2000-04-10 |