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FDA 510(k)

Termômetro de Temperatura Instantâneo ARC, Termômetro de Temperatura Instantâneo ARC MD

Número K: K152905 · 2016-07-20

RequerenteArc Devices Limited
Data da decisão2016-07-20
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Arc Devices Limited. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152905. 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 ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Arc Devices Limited. The 510(k) number is K152905.

When did ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer receive FDA 510(k) clearance?

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152905.

Who is the listed applicant for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

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

What is the FDA product code for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

The FDA product code for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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