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FDA 510(k)

Empulse M90

K-Number: K242327 · 2024-12-10

ApplicantConcourse Assistive Technology Pty, Ltd.
Decision Date2024-12-10
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Empulse M90?

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

When was Empulse M90 approved by the FDA?

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

What company makes Empulse M90?

Empulse M90 is manufactured by Concourse Assistive Technology Pty, Ltd..

What is the FDA product code for Empulse M90?

The FDA product code for Empulse M90 is ITI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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