K113215 is an FDA 510(k) clearance for the MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 14, 2012, 195 days after receiving the submission on November 1, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K113215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2011 |
| Decision Date | May 14, 2012 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |