FDA 510(k) Applications for Medical Device Product Code: QBC ()

FDA 510(k) Applications for Medical Device Product Code "QBC"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K222237	Cala Health, Inc.	Cala kIQ	11/22/2022
K242259	Cala Health, Inc.	Cala kIQ	11/22/2024
K243848	Cala Health, Inc.	Cala kIQ	01/16/2025
DEN170028	Cala Health, Inc.	Cala ONE	04/26/2018
K203288	Cala Health, Inc.	Cala Trio	10/05/2021
K182706	Cala Health, Inc.	External upper limb tremor stimulator	10/25/2018
K250096	Fasikl Incorporated	Felix NeuroAI System	07/01/2025