Cardiooptics Augmentative Cardiac Optical Imaging System
FDA 510(k) K062340 · Cardio-Optics, Inc.
510(k) numberK062340
Submission
- Device name
- Cardiooptics Augmentative Cardiac Optical Imaging System
- Applicant
- Cardio-Optics, Inc.
Boulder, CO, US - Received
- August 10, 2006
- Decision date
- November 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYK – Angioscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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More from Applied Medical Resources
| 510(k) | Device | Decision |
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| K050808 | Coronary Sinus Access Kit, Model KCS8F-01LYK · Traditional | 07/28/2005SE |
Questions and answers
When was Cardiooptics Augmentative Cardiac Optical Imaging System cleared by the FDA?
Cardiooptics Augmentative Cardiac Optical Imaging System (K062340) received a 510(k) decision of Substantially Equivalent on November 30, 2006, 112 days after the submission was received.
What is the product code of K062340?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.