FDA 510(k)

Telemetry Monitor (iT30, iT50)

N.º K: K251508 · 2026-08-06

Fecha de decisión2026-08-06

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Telemetry Monitor (iT30, iT50) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2026-08-06 under 510(k) number K251508. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Telemetry Monitor (iT30, iT50)?

Telemetry Monitor (iT30, iT50) is a medical device that received FDA 510(k) clearance on 2026-08-06. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251508.

When did Telemetry Monitor (iT30, iT50) receive FDA 510(k) clearance?

Telemetry Monitor (iT30, iT50) received FDA 510(k) clearance on 2026-08-06, under 510(k) number K251508.

Who is the listed applicant for Telemetry Monitor (iT30, iT50)?

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

What is the FDA product code for Telemetry Monitor (iT30, iT50)?

The FDA product code for Telemetry Monitor (iT30, iT50) is MHX.

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Otros registros que enlistan a Edan Instruments, Inc. como solicitante

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Fuente oficial

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