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FDA 510(k)

KENZ-45M

K-Number: K820854 · 1982-06-01

ApplicantSuzuken Co., Ltd.
Decision Date1982-06-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENZ-45M is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 1982-06-01 under 510(k) number K820854. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENZ-45M?

KENZ-45M is a medical device that received FDA 510(k) clearance on 1982-06-01. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K820854.

When did KENZ-45M receive FDA 510(k) clearance?

KENZ-45M received FDA 510(k) clearance on 1982-06-01, under 510(k) number K820854.

Who is the listed applicant for KENZ-45M?

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

What is the FDA product code for KENZ-45M?

The FDA product code for KENZ-45M is DXN.

Other records listing Suzuken Co., Ltd. as applicant

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Related Devices (Code: DXN)

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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