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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 K880357
Device Name OMNIGRAPH 6000
Applicant
TELEMED DIV.
2345 PEMBROKE AVE.
HOFFMAN ESTATES,  IL  60195
Applicant Contact FRANK LAVALLE
Correspondent
TELEMED DIV.
2345 PEMBROKE AVE.
HOFFMAN ESTATES,  IL  60195
Correspondent Contact FRANK LAVALLE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/28/1988
Decision Date 08/02/1988
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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