FDA 510(k)

LMNT O2

K 號：K250125 · 2025-03-24

決定日期2025-03-24

產品代碼OHS

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

LMNT O2 is the device name listed in this FDA 510(k) record. The listed applicant is Xplr , Ltd.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K250125. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LMNT O2?

LMNT O2 is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Xplr , Ltd.. The 510(k) number is K250125.

When did LMNT O2 receive FDA 510(k) clearance?

LMNT O2 received FDA 510(k) clearance on 2025-03-24, under 510(k) number K250125.

Who is the listed applicant for LMNT O2?

The FDA 510(k) record lists Xplr , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LMNT O2?

The FDA product code for LMNT O2 is OHS.

相關器械（代碼：OHS）

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