meddevicedb.com FDA Device Reference

Cala ONE

DEN170028 Class II Direct
Decision Date
2018-04-26
Sponsor / Applicant
Cala Health, Inc.

Technical Specification

510(k) Submission ID DEN170028
Product Code QBC
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5897
Decision Date 2018-04-26
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

Cala ONE received FDA 510(k) clearance under submission number DEN170028, sponsored by Cala Health, 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 2018-04-26.

Classification & Regulation

This clearance is catalogued under FDA product code QBC and 21 CFR 882.5897, within the Neurology review panel as a Class II device.