Cleared Traditional

Biomonitor III, Biomonitor IIIm

K200444 · Biotronik, Inc. · Cardiovascular
Apr 2020
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K200444 is an FDA 510(k) clearance for the Biomonitor III, Biomonitor IIIm, a Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) (Class II — Special Controls, product code MXD), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 23, 2020, 59 days after receiving the submission on February 24, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K200444 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2020
Decision Date April 23, 2020
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MXD — Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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