FDA 510(k)

MS-39

N.º K: K221601 · 2023-09-01

Fecha de decisión2023-09-01

Código de productoOBO

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

MS-39 is the device name listed in this FDA 510(k) record. The listed applicant is C.S.O. S.R.L.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K221601. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MS-39?

MS-39 is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is C.S.O. S.R.L.. The 510(k) number is K221601.

When did MS-39 receive FDA 510(k) clearance?

MS-39 received FDA 510(k) clearance on 2023-09-01, under 510(k) number K221601.

Who is the listed applicant for MS-39?

The FDA 510(k) record lists C.S.O. S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MS-39?

The FDA product code for MS-39 is OBO.

Dispositivos relacionados (Código: OBO)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261019ANTERIONHeidelberg Engineering GmbH K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH K252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH K240924AnterionHeidelberg Engineering GmbH

Fuente oficial

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