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FDA 510(k), K060980, VENDYS MODEL 5000 B/BC
FDA 510(k), K060980, VENDYS MODEL 5000 B/BC
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510(K) Number: K060980
Device Name: VENDYS MODEL 5000 B/BC
Manufacturer: DOUGLAS BLAKELY
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: KXA
Date Received: 04/10/2006
Decision Date: 08/16/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: VENDYS MODEL 5000 B/BC
Manufacturer: DOUGLAS BLAKELY
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: KXA
Date Received: 04/10/2006
Decision Date: 08/16/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- 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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