FDA 510(k)

iBSM

N.º K: K243837 · 2025-05-16

SolicitanteIorbit Digital Technologies Private Limited

Fecha de decisión2025-05-16

Código de productoDRG

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

iBSM is the device name listed in this FDA 510(k) record. The listed applicant is Iorbit Digital Technologies Private Limited. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243837. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the iBSM?

iBSM is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Iorbit Digital Technologies Private Limited. The 510(k) number is K243837.

When did iBSM receive FDA 510(k) clearance?

iBSM received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243837.

Who is the listed applicant for iBSM?

The FDA 510(k) record lists Iorbit Digital Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iBSM?

The FDA product code for iBSM is DRG.

Dispositivos relacionados (Código: DRG)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.