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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K102618
Device Name VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
Applicant
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
DRAEGER MEDICAL AG & CO. KG
3135 Quarry Road
Telford,  PA  18969
Correspondent Contact JOYCE KILROY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/13/2010
Decision Date 12/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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