FDA 510(k)

BTL-785MJ

K 號：K243290 · 2025-05-09

決定日期2025-05-09

產品代碼NUW

諮詢委員會PM

決定相當於

器材摘要

BTL-785MJ is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K243290. The device is classified under product code NUW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BTL-785MJ?

BTL-785MJ is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is BTL Industries, Inc.. The 510(k) number is K243290.

When did BTL-785MJ receive FDA 510(k) clearance?

BTL-785MJ received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243290.

Who is the listed applicant for BTL-785MJ?

FDA 510(k) 記錄將 BTL Industries, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for BTL-785MJ?

The FDA product code for BTL-785MJ is NUW.