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FDA 510(k)

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)

K-Number: K233308 · 2024-04-25

ApplicantNakanishi, Inc.
Decision Date2024-04-25
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) is a medical device manufactured by Nakanishi, Inc.. It received FDA 510(k) clearance on 2024-04-25 under approval number K233308. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)?

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Nakanishi, Inc.. The 510(k) number is K233308.

When was Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) approved by the FDA?

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) received FDA 510(k) clearance on 2024-04-25, under approval number K233308.

What company makes Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)?

Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) is manufactured by Nakanishi, Inc..

What is the FDA product code for Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)?

The FDA product code for Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) is EFB.

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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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