K143219 is an FDA 510(k) clearance for the NIRO-200NX. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Hamamatsu Photonics K.K. (Hamamatsu City, JP). The FDA issued a Cleared decision on July 31, 2015, 263 days after receiving the submission on November 10, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K143219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2014 |
| Decision Date | July 31, 2015 |
| Days to Decision | 263 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 |