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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 K933012
Device Name MXT-2 12 LEAD MICRO-TRANSMITTER
Applicant
Medical Electronic Record Exchange
1011 N. Mayfair Rd.
Suite 203
Milwaukee,  WI  53226
Applicant Contact EDWARD ANDREWS
Correspondent
Medical Electronic Record Exchange
1011 N. Mayfair Rd.
Suite 203
Milwaukee,  WI  53226
Correspondent Contact EDWARD ANDREWS
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/21/1993
Decision Date 03/14/1994
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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