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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K914969
Device Name E350I ELECTROCARDIOGRAPH
Applicant
Siemens Burdick, Inc.
15 Plumb St.
Miltoon,  WI  53563
Applicant Contact PAUL E.APPEL
Correspondent
Siemens Burdick, Inc.
15 Plumb St.
Miltoon,  WI  53563
Correspondent Contact PAUL E.APPEL
Classification Product Code
LOS
Date Received11/05/1991
Decision Date 03/26/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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