FDA 510(k)

BLUE 400; BLUE 400 S

Número K: K240215 · 2024-06-28

Data da decisão2024-06-28

Código do produtoQFX

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BLUE 400; BLUE 400 S is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2024-06-28 under 510(k) number K240215. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BLUE 400; BLUE 400 S?

BLUE 400; BLUE 400 S is a medical device that received FDA 510(k) clearance on 2024-06-28. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K240215.

When did BLUE 400; BLUE 400 S receive FDA 510(k) clearance?

BLUE 400; BLUE 400 S received FDA 510(k) clearance on 2024-06-28, under 510(k) number K240215.

Who is the listed applicant for BLUE 400; BLUE 400 S?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUE 400; BLUE 400 S?

The FDA product code for BLUE 400; BLUE 400 S is QFX.

Outros registros que listam Carl Zeiss Meditec, AG 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.

K260694ZEISS CLINIC 360 K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)K233911VISULAS combi K233421RESCAN 700 K232944CALLISTO eye K232159QEVO System

Ver todos os 27 dispositivos →

Dispositivos Relacionados (Código: QFX)

K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K232567Myriad SPECTRA Light SourceNico Corporation K211346BLUE 400Carl Zeiss Meditec, AG

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.