FDA 510(k), K040011, POLARIS 2004 CAPNOGRAPH
FDA 510(k), K040011, POLARIS 2004 CAPNOGRAPH
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510(K) Number: K040011
Device Name: POLARIS 2004 CAPNOGRAPH
Manufacturer: ORIDION LTD.
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 01/05/2004
Decision Date: 05/13/2004
Regulation Medical Specialty: Anesthesiology
Device Name: POLARIS 2004 CAPNOGRAPH
Manufacturer: ORIDION LTD.
Device Classification Name: analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Number: 868.1400
Classification Product Code: CCK
Date Received: 01/05/2004
Decision Date: 05/13/2004
Regulation Medical Specialty: Anesthesiology
- 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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