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FDA 510(k)

AcuPebble OX100

K-Number: K222950 · 2023-02-03

ApplicantAcurable Limited
Decision Date2023-02-03
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AcuPebble OX100 is a medical device manufactured by Acurable Limited. It received FDA 510(k) clearance on 2023-02-03 under approval number K222950. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcuPebble OX100?

AcuPebble OX100 is a medical device that received FDA 510(k) clearance on 2023-02-03. It is manufactured by Acurable Limited. The 510(k) number is K222950.

When was AcuPebble OX100 approved by the FDA?

AcuPebble OX100 received FDA 510(k) clearance on 2023-02-03, under approval number K222950.

What company makes AcuPebble OX100?

AcuPebble OX100 is manufactured by Acurable Limited.

What is the FDA product code for AcuPebble OX100?

The FDA product code for AcuPebble OX100 is MNR.

Other Devices by Acurable Limited

K210480AcuPebble SA K243092AcuPebble Ox (200)

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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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