The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Reusable Pulse Oximeter Sensor, Model 8000 Series.
| Device ID | K092101 |
| 510k Number | K092101 |
| Device Name: | REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Lori Roth |
| Correspondent | Lori 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2009-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166002294 | K092101 | 000 |
| 00833166002225 | K092101 | 000 |
| 00833166002317 | K092101 | 000 |
| 00833166002287 | K092101 | 000 |
| 00833166002232 | K092101 | 000 |
| 00833166002249 | K092101 | 000 |
| 00849686051018 | K092101 | 000 |
| 00849686051001 | K092101 | 000 |
| 00849686050998 | K092101 | 000 |