FDA 510(k), K040011, POLARIS 2004 CAPNOGRAPH

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