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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 K791975
Device Name PACING SYSTEM ANALYZER PSA SCE-22
Applicant
ELA MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ELA MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.3630
Classification Product Code
DTC  
Date Received10/02/1979
Decision Date 01/31/1980
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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