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FDA 510(k) Applications Submitted by Cala Health, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K203288
11/09/2020
Cala Trio
Cala Health, Inc.
K222237
07/26/2022
Cala kIQ
Cala Health, Inc.
DEN170028
05/17/2017
Cala ONE
Cala Health, Inc.
K182706
09/27/2018
External upper limb tremor stimulator
Cala Health, Inc.
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