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FDA 510(k), K113215, MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
FDA 510(k), K113215, MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
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510(K) Number: K113215
Device Name: MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
Manufacturer: NONIN MEDICAL, INC.
Device Classification Name: oximeter, tissue saturation
Regulation Number: 870.2700
Classification Product Code: MUD
Date Received: 11/01/2011
Decision Date: 05/14/2012
Regulation Medical Specialty: Cardiovascular
Device Name: MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
Manufacturer: NONIN MEDICAL, INC.
Device Classification Name: oximeter, tissue saturation
Regulation Number: 870.2700
Classification Product Code: MUD
Date Received: 11/01/2011
Decision Date: 05/14/2012
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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