FDA 510(k)

BIOMONITOR IIIm, BIOMONITOR III

K-Number: K221856 · 2022-07-27

Decision Date2022-07-27

Product CodeMXD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BIOMONITOR IIIm, BIOMONITOR III is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-27 under approval number K221856. 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 IIIm, BIOMONITOR III?

BIOMONITOR IIIm, BIOMONITOR III is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Biotronik, Inc.. The 510(k) number is K221856.

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

BIOMONITOR IIIm, BIOMONITOR III received FDA 510(k) clearance on 2022-07-27, under approval number K221856.

What company makes BIOMONITOR IIIm, BIOMONITOR III?

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

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

The FDA product code for BIOMONITOR IIIm, BIOMONITOR III 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.