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FDA 510(k), K072412, OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
FDA 510(k), K072412, OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
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$149.00 USD
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510(K) Number: K072412
Device Name: OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
Manufacturer: DRAGER MEDICAL AG & CO. KGAA
Device Classification Name: ventilator, continuous, facility use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 08/27/2007
Decision Date: 02/06/2008
Regulation Medical Specialty: Anesthesiology
Device Name: OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
Manufacturer: DRAGER MEDICAL AG & CO. KGAA
Device Classification Name: ventilator, continuous, facility use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 08/27/2007
Decision Date: 02/06/2008
Regulation Medical Specialty: Anesthesiology
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