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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K072412
FOIA Releasable 510(k) K072412
Device Name OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
Applicant
Drager Medical AG & Co. Kgaa
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact KATHY ANDERSON
Correspondent
Drager Medical AG & Co. Kgaa
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact KATHY ANDERSON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/27/2007
Decision Date 02/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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