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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K935394
Device Name MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
Applicant
Marquette Electronics, Inc.
100 Marquette Dr.
Jupiter,  FL  33468
Applicant Contact RICHARD A CRANE
Correspondent
Marquette Electronics, Inc.
100 Marquette Dr.
Jupiter,  FL  33468
Correspondent Contact RICHARD A CRANE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/08/1993
Decision Date 10/20/1994
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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