The following data is part of a premarket notification filed by Respironics Novametrix, Inc. with the FDA for Tidal Wave Sp Model 710/715 And 715.
| Device ID | K032971 |
| 510k Number | K032971 |
| Device Name: | TIDAL WAVE SP MODEL 710/715 AND 715 |
| Classification | Oximeter |
| Applicant | RESPIRONICS NOVAMETRIX, INC. 5 TECHNOLOGY DR. Wallingford, CT 06492 |
| Contact | Michael J Malis |
| Correspondent | Michael J Malis RESPIRONICS NOVAMETRIX, INC. 5 TECHNOLOGY DR. 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 | 2003-09-22 |
| Decision Date | 2004-08-26 |
| Summary: | summary |