FDA 510(k)

Spot Skan

Número K: K152831 · 2016-02-23

RequerenteSkanray Technologies Private Limited

Data da decisão2016-02-23

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spot Skan is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Private Limited. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K152831. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spot Skan?

Spot Skan is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Skanray Technologies Private Limited. The 510(k) number is K152831.

When did Spot Skan receive FDA 510(k) clearance?

Spot Skan received FDA 510(k) clearance on 2016-02-23, under 510(k) number K152831.

Who is the listed applicant for Spot Skan?

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

What is the FDA product code for Spot Skan?

The FDA product code for Spot Skan is DXN.

Outros registros que listam Skanray Technologies Private Limited como candidato(a)

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.

K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant K170967Intraskan DC Plus K151512Star 60

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Fonte oficial

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