The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Mdls 500a, 505a, 515a, & 7000a Oximeter.
| Device ID | K893643 |
| 510k Number | K893643 |
| Device Name: | NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER |
| Classification | Oximeter |
| Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford, CT 06492 |
| Contact | H Schiffman |
| Correspondent | 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 | 1989-05-15 |
| Decision Date | 1989-10-26 |