The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Sensmart Model X-100 Univeral Oximetry System.
| Device ID | K132402 |
| 510k Number | K132402 |
| Device Name: | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM |
| Classification | Oximeter |
| Applicant | NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth, MN 55441 -5443 |
| Contact | Brodie Pedersen |
| Correspondent | Brodie Pedersen 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 | 2013-08-01 |
| Decision Date | 2014-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00833166001907 | K132402 | 000 |
| 00833166002201 | K132402 | 000 |
| 00833166004694 | K132402 | 000 |
| 00833166004793 | K132402 | 000 |