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FDA 510(k)

MITAKA UNIARM

K-Number: K090792 · 2009-07-06

ApplicantMitaka Kohki Co., Ltd.
Decision Date2009-07-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MITAKA UNIARM is the device name listed in this FDA 510(k) record. The listed applicant is Mitaka Kohki Co., Ltd.. It received FDA 510(k) clearance on 2009-07-06 under 510(k) number K090792. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITAKA UNIARM?

MITAKA UNIARM is a medical device that received FDA 510(k) clearance on 2009-07-06. The listed applicant is Mitaka Kohki Co., Ltd.. The 510(k) number is K090792.

When did MITAKA UNIARM receive FDA 510(k) clearance?

MITAKA UNIARM received FDA 510(k) clearance on 2009-07-06, under 510(k) number K090792.

Who is the listed applicant for MITAKA UNIARM?

The FDA 510(k) record lists Mitaka Kohki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MITAKA UNIARM?

The FDA product code for MITAKA UNIARM is GCJ.

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Related Devices (Code: GCJ)

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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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