FDA 510(k)

CliniCloud Non-contact Thermometer, Model SPL1024

Número K: K161325 · 2016-06-22

RequerenteStethocloud Pty.Ltd (Clinicloud)

Data da decisão2016-06-22

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

CliniCloud Non-contact Thermometer, Model SPL1024 is the device name listed in this FDA 510(k) record. The listed applicant is Stethocloud Pty.Ltd (Clinicloud). It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K161325. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CliniCloud Non-contact Thermometer, Model SPL1024?

CliniCloud Non-contact Thermometer, Model SPL1024 is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Stethocloud Pty.Ltd (Clinicloud). The 510(k) number is K161325.

When did CliniCloud Non-contact Thermometer, Model SPL1024 receive FDA 510(k) clearance?

CliniCloud Non-contact Thermometer, Model SPL1024 received FDA 510(k) clearance on 2016-06-22, under 510(k) number K161325.

Who is the listed applicant for CliniCloud Non-contact Thermometer, Model SPL1024?

The FDA 510(k) record lists Stethocloud Pty.Ltd (Clinicloud) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CliniCloud Non-contact Thermometer, Model SPL1024?

The FDA product code for CliniCloud Non-contact Thermometer, Model SPL1024 is FLL.

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