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FDA 510(k)

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)

K-Number: K230408 · 2023-06-01

ApplicantSb-Kawasumi Laboratories, Inc.
Decision Date2023-06-01
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) is a medical device manufactured by Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2023-06-01 under approval number K230408. 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 (Model Numbers: PBMH/ PBMA/ PBM)?

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) is a medical device that received FDA 510(k) clearance on 2023-06-01. It is manufactured by Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K230408.

When was K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) approved by the FDA?

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) received FDA 510(k) clearance on 2023-06-01, under approval number K230408.

What company makes K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)?

K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) is manufactured by Sb-Kawasumi Laboratories, Inc..

What is the FDA product code for K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)?

The FDA product code for K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) is JKA.

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Other Devices by Sb-Kawasumi Laboratories, Inc.

K220799K-SHIELD Zen 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

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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