FDA 510(k)

BTL-703

Número K: K182363 · 2019-01-24

Data da decisão2019-01-24

Código do produtoIMJ

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

BTL-703 is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2019-01-24 under 510(k) number K182363. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BTL-703?

BTL-703 is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is BTL Industries, Inc.. The 510(k) number is K182363.

When did BTL-703 receive FDA 510(k) clearance?

BTL-703 received FDA 510(k) clearance on 2019-01-24, under 510(k) number K182363.

Who is the listed applicant for BTL-703?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTL-703?

The FDA product code for BTL-703 is IMJ.

Outros registros que listam BTL Industries, Inc. 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.

K262353BTL-299-F K260691BTL-699 K252963BTL-899TT K253750BTL-785NEH K252561BTL-754FF K250309BTL-199

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Fonte oficial

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