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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K954772
Device Name QUICKELS QS 200 SYSTEM
Applicant
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973 -8619
Applicant Contact FRANK FERGUSON
Correspondent
Ferguson Medical
3407 Bay Ave.
Chico,  CA  95973 -8619
Correspondent Contact FRANK FERGUSON
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/13/1995
Decision Date 07/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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