meddevicedb.com FDA Device Reference

Leica FL400

DEN180024 Class II Direct
Decision Date
2019-03-28
Sponsor / Applicant
Leica Microsystems (Schweiz) AG

Technical Specification

510(k) Submission ID DEN180024
Product Code QFX
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.4950
Decision Date 2019-03-28
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

Leica FL400 received FDA 510(k) clearance under submission number DEN180024, sponsored by Leica Microsystems (Schweiz) AG. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-03-28.

Classification & Regulation

This clearance is catalogued under FDA product code QFX and 21 CFR 882.4950, within the Neurology review panel as a Class II device.