FDA 510(k)

LOWTEM Crystal 120

Número K: K231893 · 2024-09-18

Data da decisão2024-09-18

Código do produtoMLR

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

LOWTEM Crystal 120 is the device name listed in this FDA 510(k) record. The listed applicant is Lowtem Co., Ltd.. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K231893. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LOWTEM Crystal 120?

LOWTEM Crystal 120 is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Lowtem Co., Ltd.. The 510(k) number is K231893.

When did LOWTEM Crystal 120 receive FDA 510(k) clearance?

LOWTEM Crystal 120 received FDA 510(k) clearance on 2024-09-18, under 510(k) number K231893.

Who is the listed applicant for LOWTEM Crystal 120?

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

What is the FDA product code for LOWTEM Crystal 120?

The FDA product code for LOWTEM Crystal 120 is MLR.

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