FDA 510(k)

電気乳首吸引器（HL-3058 II Pro）

K番号: K254125 · 2026-05-13

申請者Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

決定日2026-05-13

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

Electric Breast Pump (HL-3058 II Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K254125. 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 Electric Breast Pump (HL-3058 II Pro)?

Electric Breast Pump (HL-3058 II Pro) is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. The 510(k) number is K254125.

When did Electric Breast Pump (HL-3058 II Pro) receive FDA 510(k) clearance?

Electric Breast Pump (HL-3058 II Pro) received FDA 510(k) clearance on 2026-05-13, under 510(k) number K254125.

Who is the listed applicant for Electric Breast Pump (HL-3058 II Pro)?

The FDA 510(k) record lists Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Breast Pump (HL-3058 II Pro)?

The FDA product code for Electric Breast Pump (HL-3058 II Pro) is HGX.

申請者としてFimilla (Shanghai) Maternity & Baby Articles Co., Ltd.を記載するその他の記録

K252629電気乳首吸引器（HL-3058、F5112）K252630電気乳首吸引器（HL-3060、F5113）K240218電気乳首吸引器（F5055）

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