FDA 510(k)

Empulse M90

Número K: K242327 · 2024-12-10

RequerenteConcourse Assistive Technology Pty, Ltd.

Data da decisão2024-12-10

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Empulse M90 is the device name listed in this FDA 510(k) record. The listed applicant is Concourse Assistive Technology Pty, Ltd.. It received FDA 510(k) clearance on 2024-12-10 under 510(k) number K242327. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Empulse M90?

Empulse M90 is a medical device that received FDA 510(k) clearance on 2024-12-10. The listed applicant is Concourse Assistive Technology Pty, Ltd.. The 510(k) number is K242327.

When did Empulse M90 receive FDA 510(k) clearance?

Empulse M90 received FDA 510(k) clearance on 2024-12-10, under 510(k) number K242327.

Who is the listed applicant for Empulse M90?

The FDA 510(k) record lists Concourse Assistive Technology Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empulse M90?

The FDA product code for Empulse M90 is ITI.

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