The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Pulse Oximeter.
| Device ID | K102350 |
| 510k Number | K102350 |
| Device Name: | PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori M Mitchell |
| Correspondent | Lori M Mitchell 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 | 2010-08-19 |
| Decision Date | 2010-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849686066951 | K102350 | 000 |
| D040200121321 | K102350 | 000 |
| 00849686050981 | K102350 | 000 |
| 00849686051025 | K102350 | 000 |
| 00849686072655 | K102350 | 000 |
| 00849686072662 | K102350 | 000 |
| 00849686050905 | K102350 | 000 |
| 00849686050912 | K102350 | 000 |
| 00833166003222 | K102350 | 000 |
| 00833166003505 | K102350 | 000 |
| 00833166003499 | K102350 | 000 |
| 00833166003482 | K102350 | 000 |
| 00833166002386 | K102350 | 000 |
| 00833166002300 | K102350 | 000 |
| 00833166003437 | K102350 | 000 |
| 10190752168770 | K102350 | 000 |