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FDA 510(k)

3D Accuitomo 150N

K-Number: K201378 · 2021-02-18

ApplicantJ. Morita USA, Inc.
Decision Date2021-02-18
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D Accuitomo 150N is a medical device manufactured by J. Morita USA, Inc.. It received FDA 510(k) clearance on 2021-02-18 under approval number K201378. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D Accuitomo 150N?

3D Accuitomo 150N is a medical device that received FDA 510(k) clearance on 2021-02-18. It is manufactured by J. Morita USA, Inc.. The 510(k) number is K201378.

When was 3D Accuitomo 150N approved by the FDA?

3D Accuitomo 150N received FDA 510(k) clearance on 2021-02-18, under approval number K201378.

What company makes 3D Accuitomo 150N?

3D Accuitomo 150N is manufactured by J. Morita USA, Inc..

What is the FDA product code for 3D Accuitomo 150N?

The FDA product code for 3D Accuitomo 150N is OAS.

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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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