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FDA 510(k)

LFR-260

K-Nummer: K233295 · 2024-05-31

AntragstellerEvolution Optiks Limited
Entscheidungsdatum2024-05-31
ProduktcodeSBI
BeratungsausschussOP
EntscheidungSubstantially Equivalent

Produktübersicht

LFR-260 is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Optiks Limited. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K233295. The device is classified under product code SBI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the LFR-260?

LFR-260 is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Evolution Optiks Limited. The 510(k) number is K233295.

When did LFR-260 receive FDA 510(k) clearance?

LFR-260 received FDA 510(k) clearance on 2024-05-31, under 510(k) number K233295.

Who is the listed applicant for LFR-260?

The FDA 510(k) record lists Evolution Optiks Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LFR-260?

The FDA product code for LFR-260 is SBI.

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