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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, Indirect
510(k) Number K800696
Device Name ELECTRONIC PACEMAKER WAVEFORM ANALYZER
Applicant
Instromedix, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instromedix, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.3640
Classification Product Code
KRE  
Date Received03/28/1980
Decision Date 08/14/1980
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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