K190560 is an FDA 510(k) clearance for the SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface. 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 2, 2019, 58 days after receiving the submission on March 5, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K190560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2019 |
| Decision Date | May 02, 2019 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |