HOMEVUE MONITORING SYS.MODEL TD 2000

System, Monitoring, Perinatal

HOMEVUE HEALTH SYSTEMS, INC.

The following data is part of a premarket notification filed by Homevue Health Systems, Inc. with the FDA for Homevue Monitoring Sys.model Td 2000.

Pre-market Notification Details

Device IDK912138
510k NumberK912138
Device Name:HOMEVUE MONITORING SYS.MODEL TD 2000
ClassificationSystem, Monitoring, Perinatal
Applicant HOMEVUE HEALTH SYSTEMS, INC. 673 MYSTIC WAY Laguna Beach,  CA  92651
ContactGary R.mounts
CorrespondentGary R.mounts
HOMEVUE HEALTH SYSTEMS, INC. 673 MYSTIC WAY Laguna Beach,  CA  92651
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-14
Decision Date1992-03-19

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