MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100

System, Test, Blood Glucose, Over The Counter

MEDAPPS, INC.

The following data is part of a premarket notification filed by Medapps, Inc. with the FDA for Medapps Remote Patient Monitoring, Model Ma 100.

Pre-market Notification Details

Device IDK062377
510k NumberK062377
Device Name:MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant MEDAPPS, INC. 7975 NORTH HAYDEN ROAD SUITE B-200 Scottsdale,  AZ  85258
ContactKent E Dicks
CorrespondentKent E Dicks
MEDAPPS, INC. 7975 NORTH HAYDEN ROAD SUITE B-200 Scottsdale,  AZ  85258
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-15
Decision Date2007-07-03
Summary:summary

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