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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 K912138
Device Name HOMEVUE MONITORING SYS.MODEL TD 2000
Applicant
Homevue Health Systems, Inc.
673 Mystic Way
Laguna Beach,  CA  92651
Applicant Contact GARY R.MOUNTS
Correspondent
Homevue Health Systems, Inc.
673 Mystic Way
Laguna Beach,  CA  92651
Correspondent Contact GARY R.MOUNTS
Regulation Number884.2740
Classification Product Code
HGM  
Date Received05/14/1991
Decision Date 03/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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