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FDA 510(k)

Titanium Turbine

K-Number: K230888 · 2023-06-02

ApplicantNakanishi, Inc.
Decision Date2023-06-02
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Titanium Turbine is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K230888. 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 Titanium Turbine?

Titanium Turbine is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Nakanishi, Inc.. The 510(k) number is K230888.

When did Titanium Turbine receive FDA 510(k) clearance?

Titanium Turbine received FDA 510(k) clearance on 2023-06-02, under 510(k) number K230888.

Who is the listed applicant for Titanium Turbine?

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

What is the FDA product code for Titanium Turbine?

The FDA product code for Titanium Turbine is EFB.

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Related Devices (Code: 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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