ABPM 7100, Hypertension Management Software

System, Measurement, Blood-pressure, Non-invasive

I.E.M. GMBH

The following data is part of a premarket notification filed by I.e.m. Gmbh with the FDA for Abpm 7100, Hypertension Management Software.

Pre-market Notification Details

Device IDK153557
510k NumberK153557
Device Name:ABPM 7100, Hypertension Management Software
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant I.E.M. GMBH COCKERILLSTR. 69 Stolberg,  DE 52222
ContactHella Witt
CorrespondentHella Witt
I.E.M. GMBH COCKERILLSTR.69 Stolberg,  DE 52222
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-14
Decision Date2016-07-19
Summary:summary

NIH GUDID Devices

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