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FDA 510(k), K143219, NIRO-200NX
FDA 510(k), K143219, NIRO-200NX
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510(K) Number: K143219
Device Name: NIRO-200NX
Manufacturer: SUSUMU SUZUKI
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 11/10/2014
Date Received: 07/31/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: NIRO-200NX
Manufacturer: SUSUMU SUZUKI
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: 11/10/2014
Date Received: 07/31/2015
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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