meddevicedb.com FDA Device Reference

Stanza

DEN220083 Class II Direct
Decision Date
2023-05-09
Sponsor / Applicant
Swing Therapeutics, Inc.

Technical Specification

510(k) Submission ID DEN220083
Product Code QWI
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5804
Decision Date 2023-05-09
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

Stanza received FDA 510(k) clearance under submission number DEN220083, sponsored by Swing Therapeutics, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-05-09.

Classification & Regulation

This clearance is catalogued under FDA product code QWI and 21 CFR 882.5804, within the Neurology review panel as a Class II device.