The following data is part of a premarket notification filed by Respironics Novametrix, Inc. with the FDA for Spot Check Pulse Oximeter,512/513.
| Device ID | K032949 |
| 510k Number | K032949 |
| Device Name: | SPOT CHECK PULSE OXIMETER,512/513 |
| 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 | 2004-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838031555 | K032949 | 000 |
| 00884838031432 | K032949 | 000 |
| 00884838031258 | K032949 | 000 |
| 20884838031498 | K032949 | 000 |