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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K945985
Device Name PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400
Applicant
Burdick, Inc.
15 Plumb St.
Miltoon,  WI  53563
Applicant Contact RICHARD J BERK
Correspondent
Burdick, Inc.
15 Plumb St.
Miltoon,  WI  53563
Correspondent Contact RICHARD J BERK
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/08/1994
Decision Date 07/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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