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FDA 510(k) K040011, POLARIS 2004 CAPNOGRAPH, by Oridion , Ltd.

FDA 510(k) K040011, POLARIS 2004 CAPNOGRAPH, by Oridion , Ltd.

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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

Total pages: 437
Fully redacted pages: 298
Content pages: 139

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