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FDA 510(k)

BoneView

K-Number: K212365 · 2022-03-01

ApplicantGleamer
Decision Date2022-03-01
Product CodeQBS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BoneView is a medical device manufactured by Gleamer. It received FDA 510(k) clearance on 2022-03-01 under approval number K212365. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BoneView?

BoneView is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Gleamer. The 510(k) number is K212365.

When was BoneView approved by the FDA?

BoneView received FDA 510(k) clearance on 2022-03-01, under approval number K212365.

What company makes BoneView?

BoneView is manufactured by Gleamer.

What is the FDA product code for BoneView?

The FDA product code for BoneView is QBS.

Other Devices by Gleamer

K222176BoneView

Related Devices (Code: QBS)

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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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