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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 Rd.
Telford,  PA  18969
Applicant Contact JOYCE KILROY
Correspondent
Draeger Medical AG & Co. KG
3135 Quarry Rd.
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
Predetermined Change
Control Plan Authorized		 No
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