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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 K010925
Device Name SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
Applicant
Siemens Elema AB
Medical Solutions
186 Wood Ave. S.
Iselin,  NJ  08830 -2770
Applicant Contact DIANE WURZBURGER
Correspondent
Siemens Elema AB
Medical Solutions
186 Wood Ave. S.
Iselin,  NJ  08830 -2770
Correspondent Contact DIANE WURZBURGER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/27/2001
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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