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FDA 510(k)

Biomonitor III, Biomonitor IIIm

K-Number: K200444 · 2020-04-23

ApplicantBiotronik, Inc.
Decision Date2020-04-23
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Biomonitor III, Biomonitor IIIm is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2020-04-23 under approval number K200444. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biomonitor III, Biomonitor IIIm?

Biomonitor III, Biomonitor IIIm is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Biotronik, Inc.. The 510(k) number is K200444.

When was Biomonitor III, Biomonitor IIIm approved by the FDA?

Biomonitor III, Biomonitor IIIm received FDA 510(k) clearance on 2020-04-23, under approval number K200444.

What company makes Biomonitor III, Biomonitor IIIm?

Biomonitor III, Biomonitor IIIm is manufactured by Biotronik, Inc..

What is the FDA product code for Biomonitor III, Biomonitor IIIm?

The FDA product code for Biomonitor III, Biomonitor IIIm is MXD.

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Related Devices (Code: MXD)

K160809Reveal LINQMedtronic, Inc. K160689Reveal LINQMedtronic, Inc. K152995BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. K171514BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetBiotronik, Inc. K170628BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. K162855Reveal LINQMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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