HOMEVUE WOUND MONITORING SYSTEM

System, Image Processing, Radiological

HOMEVUE HEALTH SYSTEMS, INC.

The following data is part of a premarket notification filed by Homevue Health Systems, Inc. with the FDA for Homevue Wound Monitoring System.

Pre-market Notification Details

Device IDK945807
510k NumberK945807
Device Name:HOMEVUE WOUND MONITORING SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant HOMEVUE HEALTH SYSTEMS, INC. 23181 VERDUGO DR. SUITE 101 Laguna Hills,  CA  92653
ContactSteven C Miller
CorrespondentSteven C Miller
HOMEVUE HEALTH SYSTEMS, INC. 23181 VERDUGO DR. SUITE 101 Laguna Hills,  CA  92653
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-28
Decision Date1995-08-07

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