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FDA 510(k)

Kenz Cardico1211

K-Number: K172068 · 2018-06-01

ApplicantSuzuken Co., Ltd.
Decision Date2018-06-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Kenz Cardico1211 is a medical device manufactured by Suzuken Co., Ltd.. It received FDA 510(k) clearance on 2018-06-01 under approval number K172068. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kenz Cardico1211?

Kenz Cardico1211 is a medical device that received FDA 510(k) clearance on 2018-06-01. It is manufactured by Suzuken Co., Ltd.. The 510(k) number is K172068.

When was Kenz Cardico1211 approved by the FDA?

Kenz Cardico1211 received FDA 510(k) clearance on 2018-06-01, under approval number K172068.

What company makes Kenz Cardico1211?

Kenz Cardico1211 is manufactured by Suzuken Co., Ltd..

What is the FDA product code for Kenz Cardico1211?

The FDA product code for Kenz Cardico1211 is DPS.

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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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