FDA 510(k)

Wearable breast pump (Model: XN/MD-2249BS, ZFHF)

K番号: K262774 · 2026-09-01

申請者Guangdong Horigen Mother & Baby Products Co., Ltd.

決定日2026-09-01

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Substantially Equivalent

医療機器の概要

Wearable breast pump (Model: XN/MD-2249BS, ZFHF) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2026-09-01 under 510(k) number K262774. 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 Wearable breast pump (Model: XN/MD-2249BS, ZFHF)?

Wearable breast pump (Model: XN/MD-2249BS, ZFHF) is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K262774.

When did Wearable breast pump (Model: XN/MD-2249BS, ZFHF) receive FDA 510(k) clearance?

Wearable breast pump (Model: XN/MD-2249BS, ZFHF) received FDA 510(k) clearance on 2026-09-01, under 510(k) number K262774.

Who is the listed applicant for Wearable breast pump (Model: XN/MD-2249BS, ZFHF)?

The FDA 510(k) record lists Guangdong Horigen Mother & Baby Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable breast pump (Model: XN/MD-2249BS, ZFHF)?

The FDA product code for Wearable breast pump (Model: XN/MD-2249BS, ZFHF) is HGX.

申請者としてGuangdong Horigen Mother & Baby Products Co., Ltd.を記載するその他の記録

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