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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 K980884
Device Name SIEMENS SEVOFLURANE VAPORIZER SV 953
Applicant
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Applicant Contact DAVID SIMARD
Correspondent
Siemens Medical Solutions USA, Inc.
16 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact DAVID SIMARD
Regulation Number868.5880
Classification Product Code
CAD  
Date Received03/09/1998
Decision Date 08/19/1998
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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