FDA 510(k)

IRIS-XP

Número K: K212412 · 2021-09-13

Data da decisão2021-09-13

Código do produtoLHQ

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

IRIS-XP is the device name listed in this FDA 510(k) record. The listed applicant is Medicore Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K212412. The device is classified under product code LHQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IRIS-XP?

IRIS-XP is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Medicore Co., Ltd.. The 510(k) number is K212412.

When did IRIS-XP receive FDA 510(k) clearance?

IRIS-XP received FDA 510(k) clearance on 2021-09-13, under 510(k) number K212412.

Who is the listed applicant for IRIS-XP?

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

What is the FDA product code for IRIS-XP?

The FDA product code for IRIS-XP is LHQ.

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