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FDA 510(k), K112368, CAPNOSTREAM20P WITH AI/ODI
FDA 510(k), K112368, CAPNOSTREAM20P WITH AI/ODI
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510(K) Number: K112368
Device Name: CAPNOSTREAM20P WITH AI/ODI
Manufacturer: ORIDION MEDICAL 1987 LTD.
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 08/17/2011
Decision Date: 07/19/2012
Regulation Medical Specialty: Anesthesiology
Device Name: CAPNOSTREAM20P WITH AI/ODI
Manufacturer: ORIDION MEDICAL 1987 LTD.
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 08/17/2011
Decision Date: 07/19/2012
Regulation Medical Specialty: Anesthesiology
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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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