FDA 510(k)

BoneMetrics (US)

K-Number: K241593 · 2025-02-05

Decision Date2025-02-05

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BoneMetrics (US) is the device name listed in this FDA 510(k) record. The listed applicant is Gleamer Sas. It received FDA 510(k) clearance on 2025-02-05 under 510(k) 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. The listed applicant is Gleamer Sas. The 510(k) number is K241593.

When did BoneMetrics (US) receive FDA 510(k) clearance?

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

Who is the listed applicant for BoneMetrics (US)?

The FDA 510(k) record lists Gleamer Sas as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Gleamer Sas as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241620ChestView US

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Official Source

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