FDA 510(k)

ABL90 FLEX, ABL90 FLEX PLUS

Número K: K170882 · 2017-04-28

Data da decisão2017-04-28

Código do produtoMQM

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ABL90 FLEX, ABL90 FLEX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170882. The device is classified under product code MQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ABL90 FLEX, ABL90 FLEX PLUS?

ABL90 FLEX, ABL90 FLEX PLUS is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Radiometer Medical Aps. The 510(k) number is K170882.

When did ABL90 FLEX, ABL90 FLEX PLUS receive FDA 510(k) clearance?

ABL90 FLEX, ABL90 FLEX PLUS received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170882.

Who is the listed applicant for ABL90 FLEX, ABL90 FLEX PLUS?

The FDA 510(k) record lists Radiometer Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABL90 FLEX, ABL90 FLEX PLUS?

The FDA product code for ABL90 FLEX, ABL90 FLEX PLUS is MQM.

Outros registros que listam Radiometer Medical Aps 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.

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Fonte oficial

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