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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 the device name listed in this FDA 510(k) record. The listed applicant is Sb-Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2023-06-01 under 510(k) 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. The listed applicant is Sb-Kawasumi Laboratories, Inc.. The 510(k) number is K230408.

When did K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) receive FDA 510(k) clearance?

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

Who is the listed applicant for K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)?

The FDA 510(k) record lists Sb-Kawasumi Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sb-Kawasumi Laboratories, Inc. as applicant

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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Related Devices (Code: JKA)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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