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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 K803286
Device Name CARDIOMEMO
Applicant
Instromedix, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Instromedix, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3640
Classification Product Code
KRE  
Date Received12/30/1980
Decision Date 03/17/1981
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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