BIOMONITOR IIIm, BIOMONITOR III

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 Iiim, Biomonitor Iii.

Pre-market Notification Details

Device IDK221856
510k NumberK221856
Device Name:BIOMONITOR IIIm, BIOMONITOR III
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-27
Decision Date2022-07-27

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