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FDA 510(k)

KEISEI

K-Number: K950613 · 1996-02-14

ApplicantKeisei (Usa) Co., Ltd.
Decision Date1996-02-14
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KEISEI is the device name listed in this FDA 510(k) record. The listed applicant is Keisei (Usa) Co., Ltd.. It received FDA 510(k) clearance on 1996-02-14 under 510(k) number K950613. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEISEI?

KEISEI is a medical device that received FDA 510(k) clearance on 1996-02-14. The listed applicant is Keisei (Usa) Co., Ltd.. The 510(k) number is K950613.

When did KEISEI receive FDA 510(k) clearance?

KEISEI received FDA 510(k) clearance on 1996-02-14, under 510(k) number K950613.

Who is the listed applicant for KEISEI?

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

What is the FDA product code for KEISEI?

The FDA product code for KEISEI is CAE.

Related Clinical Trials

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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Other records listing Keisei (Usa) 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.

K925651LIFE ISLAND 21

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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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