Data da decisão2025-03-24
Código do produtoOHS
Comité consultivoSU
DecisãoSubstantially Equivalent
Resumo do dispositivo
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.
Perguntas frequentes
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.
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Fonte oficial
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