FDA 510(k), K062340, CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM

FDA 510(k), K062340, CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM

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510(K) Number: K062340
Device Name: CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
Manufacturer: LARRY BLANKENSHIP
Device Classification Name: Angioscope
Regulation Number: LYK
Classification Product Code: KXA
Date Received: 08/10/2006
Decision Date: 11/30/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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