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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function
510(k) Number K800286
Device Name CRITERION II PACING SYSTEM MONITORS
Applicant
Dart Medical Equipment
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dart Medical Equipment
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.3630
Classification Product Code
DTC  
Date Received02/08/1980
Decision Date 03/12/1980
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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