Biomonitor III, Biomonitor IIIm

Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

BIOTRONIK, Inc.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Biomonitor Iii, Biomonitor Iiim.

Pre-market Notification Details

Device IDK200444
510k NumberK200444
Device Name:Biomonitor III, Biomonitor IIIm
ClassificationRecorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Applicant BIOTRONIK, Inc. 6024 Jean Road Lake Oswego,  OR  97035
ContactJon Brumbaugh
CorrespondentJon Brumbaugh
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego,  OR  97035
Product CodeMXD  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-04-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04035479169862 K200444 000

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