meddevicedb.com FDA Device Reference

Delphi-MD System

DEN250002 Class II Direct
Decision Date
2025-08-20
Sponsor / Applicant
Quantalx Neuroscience, Ltd.

Technical Specification

510(k) Submission ID DEN250002
Product Code SFN
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1860
Decision Date 2025-08-20
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Delphi-MD System received FDA 510(k) clearance under submission number DEN250002, sponsored by Quantalx Neuroscience, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-08-20.

Classification & Regulation

This clearance is catalogued under FDA product code SFN and 21 CFR 882.1860, within the Neurology review panel as a Class II device.