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FDA 510(k)

BIOMONITOR IV (471155)

K-Number: K261074 · 2026-05-01

ApplicantBiotronik, Inc.
Decision Date2026-05-01
Product CodeMXD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOMONITOR IV (471155) is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2026-05-01 under approval number K261074. 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 IV (471155)?

BIOMONITOR IV (471155) is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by Biotronik, Inc.. The 510(k) number is K261074.

When was BIOMONITOR IV (471155) approved by the FDA?

BIOMONITOR IV (471155) received FDA 510(k) clearance on 2026-05-01, under approval number K261074.

What company makes BIOMONITOR IV (471155)?

BIOMONITOR IV (471155) is manufactured by Biotronik, Inc..

What is the FDA product code for BIOMONITOR IV (471155)?

The FDA product code for BIOMONITOR IV (471155) is MXD.

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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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