FDA 510(k)

!M1

Número K: K170607 · 2017-07-17

Data da decisão2017-07-17

Código do produtoIZL

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

!M1 is the device name listed in this FDA 510(k) record. The listed applicant is Solutions For Tomorrow AB. It received FDA 510(k) clearance on 2017-07-17 under 510(k) number K170607. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the !M1?

!M1 is a medical device that received FDA 510(k) clearance on 2017-07-17. The listed applicant is Solutions For Tomorrow AB. The 510(k) number is K170607.

When did !M1 receive FDA 510(k) clearance?

!M1 received FDA 510(k) clearance on 2017-07-17, under 510(k) number K170607.

Who is the listed applicant for !M1?

The FDA 510(k) record lists Solutions For Tomorrow AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for !M1?

The FDA product code for !M1 is IZL.

Outros registros que listam Solutions For Tomorrow AB 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.

K251710Mobile X-ray unit (!M1)K241980!M1

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Fonte oficial

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