Entscheidungsdatum2025-03-24
ProduktcodeOHS
BeratungsausschussSU
EntscheidungSubstantially Equivalent
Produktübersicht
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.
Häufig gestellte Fragen
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.
Verwandte Geräte (Code: OHS)
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Offizielle Quelle
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