Name: Predicase
Price: 199 USD

K-number	K242327
Device name	Empulse M90
Applicant	Concourse Assistive Technology Pty, Ltd.
Product code	ITI
Device class	Class II
Decision date	Dec 10, 2024
Decision	Substantially Equivalent
Regulation	890.3860

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Empulse M90

Everything you need for a 510(k) submission. Nothing you don't.