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FDA 510(k)

KENZ 80Z MARK II

K-Number: K843731 · 1985-07-11

ApplicantSuzuken Co., Ltd.
Decision Date1985-07-11
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENZ 80Z MARK II 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 1985-07-11 under 510(k) number K843731. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENZ 80Z MARK II?

KENZ 80Z MARK II is a medical device that received FDA 510(k) clearance on 1985-07-11. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K843731.

When did KENZ 80Z MARK II receive FDA 510(k) clearance?

KENZ 80Z MARK II received FDA 510(k) clearance on 1985-07-11, under 510(k) number K843731.

Who is the listed applicant for KENZ 80Z MARK II?

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 80Z MARK II?

The FDA product code for KENZ 80Z MARK II is DSI.

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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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