Name: Predicase
Price: 199 USD

K-number	DEN250002
Device name	Delphi-MD System
Applicant	Quantalx Neuroscience, Ltd.
Product code	SFN
Device class	Class II
Decision date	Aug 20, 2025
Decision	Not Substantially Equivalent
Regulation	882.1860

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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Delphi-MD System

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