FDA 510(k)

Kidro デジタル電動搾乳器、Dr. Brown's デジタル電動搾乳器

K番号: K192640 · 2020-03-30

申請者Guangzhou Yongyi Industrial Co., Ltd.

決定日2020-03-30

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

Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Yongyi Industrial Co., Ltd.. It received FDA 510(k) clearance on 2020-03-30 under 510(k) number K192640. 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 Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump?

Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2020-03-30. The listed applicant is Guangzhou Yongyi Industrial Co., Ltd.. The 510(k) number is K192640.

When did Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump receive FDA 510(k) clearance?

Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump received FDA 510(k) clearance on 2020-03-30, under 510(k) number K192640.

Who is the listed applicant for Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump?

The FDA 510(k) record lists Guangzhou Yongyi Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump?

The FDA product code for Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump is HGX.

申請者としてGuangzhou Yongyi Industrial Co., Ltd.を記載するその他の記録

K223329電動搾乳器（型式：YY-A46、YY-A203、YY-A204、YY-TC201）

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