meddevicedb.com FDA Device Reference

Nautilus BrainPulse 1000

DEN140040 Class II Direct
Decision Date
2016-08-01
Sponsor / Applicant
Jan Medical, Inc.

Technical Specification

510(k) Submission ID DEN140040
Product Code POP
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.1630
Decision Date 2016-08-01
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

Nautilus BrainPulse 1000 received FDA 510(k) clearance under submission number DEN140040, sponsored by Jan Medical, 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 2016-08-01.

Classification & Regulation

This clearance is catalogued under FDA product code POP and 21 CFR 882.1630, within the Neurology review panel as a Class II device.