FDA 510(k)

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

K番号: K261298 · 2026-08-20

申請者Guangdong Youmeng Electrical Technology Co., Ltd.

決定日2026-08-20

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

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K261298. 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 Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))?

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. The 510(k) number is K261298.

When did Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) receive FDA 510(k) clearance?

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) received FDA 510(k) clearance on 2026-08-20, under 510(k) number K261298.

Who is the listed applicant for Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))?

FDA 510(k)レコードでは、広東省優盟電気技術有限公司が申請者として記載されています。これは、そのままにして装置製造業者を確定することはできません。

What is the FDA product code for Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))?

ウェアラブル電動搾乳器（YM-8837、YM-8838、YM-8856(H03)、YM-8809(S42)）のFDAプロダクトコードはHGXです。

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

K252342電気乳首吸引器（YM-8807、YM-8805、YM-8806、YM-8810）K252754Wearable Electric Breast Pump (YM-8803)K232466電動搾乳器、型番: YM-8166

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