K163070 is an FDA 510(k) clearance for the Kent Camera. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Kent Imaging, Inc. (Calgary, CA). The FDA issued a Cleared decision on May 5, 2017, 184 days after receiving the submission on November 2, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K163070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2016 |
| Decision Date | May 05, 2017 |
| Days to Decision | 184 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 |