The following data is part of a premarket notification filed by Cardio-optics, Inc. with the FDA for Cardiooptics Augmentative Cardiac Optical Imaging System.
| Device ID | K062340 |
| 510k Number | K062340 |
| Device Name: | CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM |
| Classification | Angioscope |
| Applicant | CARDIO-OPTICS, INC. 2425 55TH ST., SUITE 100 Boulder, CO 80301 |
| Contact | Larry Blankenship |
| Correspondent | Larry Blankenship CARDIO-OPTICS, INC. 2425 55TH ST., SUITE 100 Boulder, CO 80301 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-10 |
| Decision Date | 2006-11-30 |
| Summary: | summary |