K062340 is an FDA 510(k) clearance for the CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM. This device is classified as a Angioscope (Class II - Special Controls, product code LYK).
Submitted by Cardio-Optics, Inc. (Boulder, US). The FDA issued a Cleared decision on November 30, 2006, 112 days after receiving the submission on August 10, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K062340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2006 |
| Decision Date | November 30, 2006 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LYK — Angioscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |