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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K955891
Device Name CARDIOVIEW TRANSTELEPHONIC SOFTWARE
Applicant
Micromedical, Inc.
1151 Hope St.
Stamford,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
Micromedical, Inc.
1151 Hope St.
Stamford,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/29/1995
Decision Date 10/08/1996
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
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