FDA 510(k)

スマートダブルサイドウェアラブルブストポンプ、電動両側ブストポンプ

K番号: K230102 · 2023-09-21

申請者Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

決定日2023-09-21

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

Smart double sides wearable breast pump, Electric bilateral breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K230102. 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 Smart double sides wearable breast pump, Electric bilateral breast pump?

Smart double sides wearable breast pump, Electric bilateral breast pump is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. The 510(k) number is K230102.

When did Smart double sides wearable breast pump, Electric bilateral breast pump receive FDA 510(k) clearance?

Smart double sides wearable breast pump, Electric bilateral breast pump received FDA 510(k) clearance on 2023-09-21, under 510(k) number K230102.

Who is the listed applicant for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA 510(k) record lists Huizhou Lvb Maternal and Infant Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump is HGX.

申請者としてHuizhou Lvb Maternal and Infant Supplies Co., Ltd.を記載するその他の記録

K252192ウェアラブルブストプンプ（P9、P10、P16、P20、P21、P22、P23、P25）K241004ウェアラブルブストプンプ（ABP-1508PRO、ABP-1506、ABP-1306、ABP-1306 PRO、M1、M3、M8、M5、M6、K1、K2、K3、K5、ABP-1306PLUS、ABP-1308、M2）

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。