CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM

Transmitters And Receivers, Physiological Signal, Radiofrequency

CONSTANT CARE, LLC

The following data is part of a premarket notification filed by Constant Care, Llc with the FDA for Constant Care Lilah Home Health Monitoring System.

Pre-market Notification Details

Device IDK120941
510k NumberK120941
Device Name:CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant CONSTANT CARE, LLC 1300 I ST, NW, 11TH FLOOR EAST Washington,  DC  20005 -3314
ContactSeth A Mailhot
CorrespondentSeth A Mailhot
CONSTANT CARE, LLC 1300 I ST, NW, 11TH FLOOR EAST Washington,  DC  20005 -3314
Product CodeDRG  
Subsequent Product CodeDQA
Subsequent Product CodeDXN
Subsequent Product CodeFLL
Subsequent Product CodeFRI
Subsequent Product CodeNBW
Subsequent Product CodeNXQ
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-29
Decision Date2012-07-03
Summary:summary

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