FDA 510(k)

電動搾乳器（モデル：RH-228およびRH-338）

K番号: K201903 · 2021-04-09

申請者Cixi Ruihong Electric Appliance Co., Ltd.

決定日2021-04-09

製品コードHGX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Electric breast pump (Models: RH-228 and RH-338) is the device name listed in this FDA 510(k) record. The listed applicant is Cixi Ruihong Electric Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K201903. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Electric breast pump (Models: RH-228 and RH-338)?

Electric breast pump (Models: RH-228 and RH-338) is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Cixi Ruihong Electric Appliance Co., Ltd.. The 510(k) number is K201903.

When did Electric breast pump (Models: RH-228 and RH-338) receive FDA 510(k) clearance?

Electric breast pump (Models: RH-228 and RH-338) received FDA 510(k) clearance on 2021-04-09, under 510(k) number K201903.

Who is the listed applicant for Electric breast pump (Models: RH-228 and RH-338)?

The FDA 510(k) record lists Cixi Ruihong Electric Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric breast pump (Models: RH-228 and RH-338)?

The FDA product code for Electric breast pump (Models: RH-228 and RH-338) is HGX.

申請者としてCixi Ruihong Electric Appliance Co., Ltd.を記載するその他の記録

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