K113507 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 August 8, 2012, 254 days after receiving the submission on November 28, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K113507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2011 |
| Decision Date | August 08, 2012 |
| Days to Decision | 254 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 |