FDA 510(k)

可攜式氧氣濃縮器（JM-P50A）

K 號：K251130 · 2025-08-21

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

決定日期2025-08-21

產品代碼CAW

諮詢委員會AN

決定相當於

器材摘要

Portable Oxygen Concentrator (JM-P50A) 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 2025-08-21 under 510(k) number K251130. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Portable Oxygen Concentrator (JM-P50A)?

Portable Oxygen Concentrator (JM-P50A) is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. The 510(k) number is K251130.

When did Portable Oxygen Concentrator (JM-P50A) receive FDA 510(k) clearance?

Portable Oxygen Concentrator (JM-P50A) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251130.

Who is the listed applicant for Portable Oxygen Concentrator (JM-P50A)?

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 Portable Oxygen Concentrator (JM-P50A)?

The FDA product code for Portable Oxygen Concentrator (JM-P50A) is CAW.