Cala kIQ Plus— 510(k) K253587

Substantially Equivalent

Cala Health, Inc.

FDA 510(k) clearance K253587 for Cala kIQ Plus, Substantially Equivalent on 2026-03-17. Applicant: Cala Health, Inc..

Clearance details

Applicant: Cala Health, Inc.
Product code: Code QBC
Advisory panel: Neurology
Date received: 2025-11-17
Decision date: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

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