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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 the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) 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. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K201378.

When did 3D Accuitomo 150N receive FDA 510(k) clearance?

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

Who is the listed applicant for 3D Accuitomo 150N?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing J. Morita USA, Inc. 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.

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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.

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