FDA 510(k)

INSULCLOCK® v2.0 PRO

Número K: K241803 · 2024-08-22

Data da decisão2024-08-22

Código do produtoQOG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

INSULCLOCK® v2.0 PRO is the device name listed in this FDA 510(k) record. The listed applicant is Insulcloud S.L.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241803. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INSULCLOCK® v2.0 PRO?

INSULCLOCK® v2.0 PRO is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Insulcloud S.L.. The 510(k) number is K241803.

When did INSULCLOCK® v2.0 PRO receive FDA 510(k) clearance?

INSULCLOCK® v2.0 PRO received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241803.

Who is the listed applicant for INSULCLOCK® v2.0 PRO?

The FDA 510(k) record lists Insulcloud S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSULCLOCK® v2.0 PRO?

The FDA product code for INSULCLOCK® v2.0 PRO is QOG.

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