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FDA 510(k), K060065, CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
FDA 510(k), K060065, CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
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510(K) Number: K060065
Device Name: CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
Manufacturer: ORIDION CAPNOGRAPHY, INC.
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 01/09/2006
Decision Date: 05/04/2006
Regulation Medical Specialty: Cardiovascular
Device Name: CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
Manufacturer: ORIDION CAPNOGRAPHY, INC.
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 01/09/2006
Decision Date: 05/04/2006
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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