FDA 510(k), K123108, TVC IMAGING SYSTEM MODEL NIRS-MC7-70

FDA 510(k), K123108, TVC IMAGING SYSTEM MODEL NIRS-MC7-70

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510(K) Number: K123108
Device Name: TVC IMAGING SYSTEM MODEL NIRS-MC7-70
Manufacturer: STEVEN J CHARTIER
Device Classification Name: Catheter, Intravascular, Plaque Morphology Evaluation
Regulation Number: OGZ
Classification Product Code: 10/03/2012
Date Received: 03/15/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular

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