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FDA 510(k), K101995, CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
FDA 510(k), K101995, CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
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510(K) Number: K101995
Device Name: CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
Manufacturer: ORIDION CAPNOGRAPHY, INC.
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 07/14/2010
Decision Date: 01/11/2011
Regulation Medical Specialty: Cardiovascular
Device Name: CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
Manufacturer: ORIDION CAPNOGRAPHY, INC.
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 07/14/2010
Decision Date: 01/11/2011
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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