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FDA 510(k)

KOWA KT-800

K-Number: K053444 · 2006-06-09

ApplicantKowa Co. , Ltd.
Decision Date2006-06-09
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA KT-800 is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Co. , Ltd.. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K053444. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA KT-800?

KOWA KT-800 is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is Kowa Co. , Ltd.. The 510(k) number is K053444.

When did KOWA KT-800 receive FDA 510(k) clearance?

KOWA KT-800 received FDA 510(k) clearance on 2006-06-09, under 510(k) number K053444.

Who is the listed applicant for KOWA KT-800?

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

What is the FDA product code for KOWA KT-800?

The FDA product code for KOWA KT-800 is HKX.

Other records listing Kowa Co. , Ltd. 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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Related Devices (Code: HKX)

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

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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