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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaporizer, Anesthesia, Non-Heated
510(k) Number K981472
Device Name DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
Applicant
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Applicant Contact J. TERESA DORRIETY
Correspondent
Draeger Medical, Inc.
3135 Quarry Rd.
Telford,  PA  18969
Correspondent Contact J. TERESA DORRIETY
Regulation Number868.5880
Classification Product Code
CAD  
Date Received04/24/1998
Decision Date 05/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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