FDA 510(k), K093923, CEROX MODEL 3210
FDA 510(k), K093923, CEROX MODEL 3210
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510(K) Number: K093923
Device Name: CEROX MODEL 3210
Manufacturer: MICHAL BALBERG, PHD
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 12/22/2009
Date Received: 01/19/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CEROX MODEL 3210
Manufacturer: MICHAL BALBERG, PHD
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 12/22/2009
Date Received: 01/19/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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.
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