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FDA 510(k)

BCM2-Body Composition Monitor

K-Number: K250634 · 2025-11-24

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2025-11-24
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BCM2-Body Composition Monitor is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-11-24 under approval number K250634. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCM2-Body Composition Monitor?

BCM2-Body Composition Monitor is a medical device that received FDA 510(k) clearance on 2025-11-24. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K250634.

When was BCM2-Body Composition Monitor approved by the FDA?

BCM2-Body Composition Monitor received FDA 510(k) clearance on 2025-11-24, under approval number K250634.

What company makes BCM2-Body Composition Monitor?

BCM2-Body Composition Monitor is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for BCM2-Body Composition Monitor?

The FDA product code for BCM2-Body Composition Monitor is DSB.

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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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