FDA 510(k)

K-SHIELD Zen

K-Number: K220799 · 2022-08-29

Decision Date2022-08-29

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

K-SHIELD Zen is a medical device manufactured by Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2022-08-29 under approval number K220799. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-SHIELD Zen?

K-SHIELD Zen is a medical device that received FDA 510(k) clearance on 2022-08-29. It is manufactured by Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K220799.

When was K-SHIELD Zen approved by the FDA?

K-SHIELD Zen received FDA 510(k) clearance on 2022-08-29, under approval number K220799.

What company makes K-SHIELD Zen?

K-SHIELD Zen is manufactured by Sb-Kawasumi Laboratories, Inc..

What is the FDA product code for K-SHIELD Zen?

The FDA product code for K-SHIELD Zen is JKA.

Other Devices by Sb-Kawasumi Laboratories, Inc.

K230408K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) K223810Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing K241855SB Knife Jr2 (MD-47702 and MD-47702L)

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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.