FDA 510(k)

可攜式痰液吸引器（JMA D01）

K 號：K250964 · 2026-05-11

申請人Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

決定日期2026-05-11

產品代碼JCX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Protable Phlegm Suction Unit (JMA D01) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-05-11 under 510(k) number K250964. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Protable Phlegm Suction Unit (JMA D01)?

Protable Phlegm Suction Unit (JMA D01) is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. The 510(k) number is K250964.

When did Protable Phlegm Suction Unit (JMA D01) receive FDA 510(k) clearance?

Protable Phlegm Suction Unit (JMA D01) received FDA 510(k) clearance on 2026-05-11, under 510(k) number K250964.

Who is the listed applicant for Protable Phlegm Suction Unit (JMA D01)?

The FDA 510(k) record lists Jiangsu Jumao X-Care Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protable Phlegm Suction Unit (JMA D01)?

The FDA product code for Protable Phlegm Suction Unit (JMA D01) is JCX.