FDA 510(k)

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

Número K: K230408 · 2023-06-01

RequerenteSb-Kawasumi Laboratories, Inc.

Data da decisão2023-06-01

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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