CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM— 510(k) K062340

Name: FDA 510(k) clearance K062340
Creator: U.S. Food and Drug Administration
Published: 2006-11-30

Substantially Equivalent

Cardio-Optics, Inc.

FDA 510(k) clearance K062340 for CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM, Substantially Equivalent on 2006-11-30. Applicant: Cardio-Optics, Inc.. Device class: 2.

Clearance details

Applicant: Cardio-Optics, Inc.
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-08-10
Decision date: 2006-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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