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FDA 510(k)

BoneMetrics (US)

K-Number: K241593 · 2025-02-05

ApplicantGleamer Sas
Decision Date2025-02-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BoneMetrics (US) is a medical device manufactured by Gleamer Sas. It received FDA 510(k) clearance on 2025-02-05 under approval number K241593. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BoneMetrics (US)?

BoneMetrics (US) is a medical device that received FDA 510(k) clearance on 2025-02-05. It is manufactured by Gleamer Sas. The 510(k) number is K241593.

When was BoneMetrics (US) approved by the FDA?

BoneMetrics (US) received FDA 510(k) clearance on 2025-02-05, under approval number K241593.

What company makes BoneMetrics (US)?

BoneMetrics (US) is manufactured by Gleamer Sas.

What is the FDA product code for BoneMetrics (US)?

The FDA product code for BoneMetrics (US) is QIH.

Other Devices by Gleamer Sas

K241620ChestView US

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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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