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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 K832903
Device Name ESOPHOGRAL MULTIPROBE
Applicant
VITAL SIGNS, INC.
1 MADISON ST.
EAST RUTHERFORD,  NJ  07073
Applicant Contact John C Riley
Correspondent
VITAL SIGNS, INC.
1 MADISON ST.
EAST RUTHERFORD,  NJ  07073
Correspondent Contact John C Riley
Regulation Number870.2360
Classification Product Code
DRX  
Date Received08/29/1983
Decision Date 05/23/1984
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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