FDA 510(k)

Youha電動搾乳器

K番号: K163136 · 2017-07-31

申請者Ningbo Youhe Electrical Appliance Technology Co., Ltd.

決定日2017-07-31

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

Youha electric breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K163136. 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 Youha electric breast pump?

Youha electric breast pump is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K163136.

When did Youha electric breast pump receive FDA 510(k) clearance?

Youha electric breast pump received FDA 510(k) clearance on 2017-07-31, under 510(k) number K163136.

Who is the listed applicant for Youha electric breast pump?

The FDA 510(k) record lists Ningbo Youhe Electrical Appliance Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Youha electric breast pump?

The FDA product code for Youha electric breast pump is HGX.

申請者としてNingbo Youhe Electrical Appliance Technology Co., Ltd.を記載するその他の記録

K251977電気式乳首吸引器（FZ-P8）；電気式乳首吸引器（YH-P8）；電気式乳首吸引器（YH-P8X）K242725Youha 電動搾乳器 (The INs、The INs Gen2、The INs NEXT、および P3) と BEBEBAO 電動搾乳器 (P1s)K203148Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030)；Bebebao Electric Breast Pump (Model: BB-5020)；Yiyadodo Electric Breast Pump (Model: YY-5030)

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。