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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, monitoring, perinatal
510(k) Number K965008
Device Name BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
Applicant
SPACELABS MEDICAL, INC.
925 SHERMAN AVE.
HAMDEN,  CT  06514
Applicant Contact ANTHONY CALDERONI
Correspondent
SPACELABS MEDICAL, INC.
925 SHERMAN AVE.
HAMDEN,  CT  06514
Correspondent Contact ANTHONY CALDERONI
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/16/1996
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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