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FDA 510(k), K183195, VIVO
FDA 510(k), K183195, VIVO
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510(K) Number: K183195
Device Name: VIVO
Manufacturer: Steve Adler
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: 11/19/2018
Date Received: 06/14/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: VIVO
Manufacturer: Steve Adler
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: 11/19/2018
Date Received: 06/14/2019
Decision Date: 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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