FDA 510(k)

BTL-785NEH

Número K: K253750 · 2026-03-17

Data da decisão2026-03-17

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BTL-785NEH 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 2026-03-17 under 510(k) number K253750. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BTL-785NEH?

BTL-785NEH is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is BTL Industries, Inc.. The 510(k) number is K253750.

When did BTL-785NEH receive FDA 510(k) clearance?

BTL-785NEH received FDA 510(k) clearance on 2026-03-17, under 510(k) number K253750.

Who is the listed applicant for BTL-785NEH?

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-785NEH?

The FDA product code for BTL-785NEH is GEI.

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 K252561BTL-754FF K250309BTL-199 K243290BTL-785MJ

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Fonte oficial

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