FDA 510(k)

吸引ポンプ（SU-90）

K番号: K260892 · 2026-05-14

申請者Shenzhen HugeMed Medical Technical Development Co., Ltd.

決定日2026-05-14

製品コードBTA

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Suction Pump (SU-90) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260892. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Suction Pump (SU-90)?

Suction Pump (SU-90) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K260892.

When did Suction Pump (SU-90) receive FDA 510(k) clearance?

Suction Pump (SU-90) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260892.

Who is the listed applicant for Suction Pump (SU-90)?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Suction Pump (SU-90)?

The FDA product code for Suction Pump (SU-90) is BTA.

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