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FDA 510(k), K190205, HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
FDA 510(k), K190205, HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
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$149.00 USD
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510(K) Number: K190205
Device Name: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
Manufacturer: Chirag Shah
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: 02/04/2019
Date Received: 08/29/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
Manufacturer: Chirag Shah
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: 02/04/2019
Date Received: 08/29/2019
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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