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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K902716
Device Name PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)
Applicant
Prucka Engineering, Inc.
8030 El Rio
Houston,  TX  77054
Applicant Contact SHERYL S PRUCKA
Correspondent
Prucka Engineering, Inc.
8030 El Rio
Houston,  TX  77054
Correspondent Contact SHERYL S PRUCKA
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/20/1990
Decision Date 09/04/1990
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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