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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, cardiac, fetal
510(k) Number K760968
Device Name CENTRAL STATION REPEATER (MODEL 8032A)
Applicant
HEWLETT-PACKARD CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HEWLETT-PACKARD CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2600
Classification Product Code
KXN  
Date Received11/04/1976
Decision Date 12/17/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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