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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K965101
Device Name CARDIOBEEPER CB-12L
Applicant
Meridian Medical Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
Meridian Medical Technologies, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received12/20/1996
Decision Date 03/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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