Cala kIQ— 510(k) K243848

Substantially Equivalent

Cala Health, Inc.

FDA 510(k) clearance K243848 for Cala kIQ, Substantially Equivalent on 2025-01-16. Applicant: Cala Health, Inc..

Clearance details

Applicant: Cala Health, Inc.
Product code: Code QBC
Advisory panel: Neurology
Date received: 2024-12-16
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: San Mateo, CA, US

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