The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Lifesense, Model Ls1-9r.
| Device ID | K063752 |
| 510k Number | K063752 |
| Device Name: | LIFESENSE, MODEL LS1-9R |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori M Roth |
| Correspondent | Lori M Roth NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849686075410 | K063752 | 000 |
| 00849686066937 | K063752 | 000 |
| 00849686088359 | K063752 | 000 |
| 00849686088106 | K063752 | 000 |
| 00849686072136 | K063752 | 000 |
| 00849686075472 | K063752 | 000 |
| 00833166005387 | K063752 | 000 |
| 00833166001570 | K063752 | 000 |
| 00849686070941 | K063752 | 000 |