The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Single-patient Use Disposable Sensor.
| Device ID | K093306 |
| 510k Number | K093306 |
| Device Name: | SINGLE-PATIENT USE DISPOSABLE SENSOR |
| 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 | 2009-10-22 |
| Decision Date | 2010-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166001846 | K093306 | 000 |
| 00833166001853 | K093306 | 000 |