1
/
of
0
FDA 510(k), K123108, TVC IMAGING SYSTEM MODEL NIRS-MC7-70
FDA 510(k), K123108, TVC IMAGING SYSTEM MODEL NIRS-MC7-70
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
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: KXA
Date Received: 10/03/2012
Decision Date: 03/15/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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: KXA
Date Received: 10/03/2012
Decision Date: 03/15/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details