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FDA 510(k)

Cala kIQ

K-Number: K243848 · 2025-01-16

ApplicantCala Health, Inc.
Decision Date2025-01-16
Product CodeQBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cala kIQ is a medical device manufactured by Cala Health, Inc.. It received FDA 510(k) clearance on 2025-01-16 under approval number K243848. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cala kIQ?

Cala kIQ is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Cala Health, Inc.. The 510(k) number is K243848.

When was Cala kIQ approved by the FDA?

Cala kIQ received FDA 510(k) clearance on 2025-01-16, under approval number K243848.

What company makes Cala kIQ?

Cala kIQ is manufactured by Cala Health, Inc..

What is the FDA product code for Cala kIQ?

The FDA product code for Cala kIQ is QBC.

Other Devices by Cala Health, Inc.

K182706External upper limb tremor stimulator DEN170028Cala ONE K203288Cala Trio K222237Cala kIQ K242259Cala kIQ K253587Cala kIQ Plus

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Related Devices (Code: QBC)

K182706External upper limb tremor stimulatorCala Health, Inc. DEN170028Cala ONECala Health, Inc. K203288Cala TrioCala Health, Inc. K222237Cala kIQCala Health, Inc. K242259Cala kIQCala Health, Inc. K250096Felix NeuroAI SystemFasikl Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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