FDA 510(k)

コンフォートゴウン、セーフウェアゴウン

K番号: K213893 · 2022-12-21

申請者Xuchang Zhengde Environstar Medical Products Co., Ltd.

決定日2022-12-21

製品コードFYA

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Comfort Gown, Safewear Gown is the device name listed in this FDA 510(k) record. The listed applicant is Xuchang Zhengde Environstar Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K213893. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Comfort Gown, Safewear Gown?

Comfort Gown, Safewear Gown is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Xuchang Zhengde Environstar Medical Products Co., Ltd.. The 510(k) number is K213893.

When did Comfort Gown, Safewear Gown receive FDA 510(k) clearance?

Comfort Gown, Safewear Gown received FDA 510(k) clearance on 2022-12-21, under 510(k) number K213893.

Who is the listed applicant for Comfort Gown, Safewear Gown?

The FDA 510(k) record lists Xuchang Zhengde Environstar Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comfort Gown, Safewear Gown?

The FDA product code for Comfort Gown, Safewear Gown is FYA.

申請者としてXuchang Zhengde Environstar Medical Products Co., Ltd.を記載するその他の記録

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