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FDA 510(k)

Cala Trio

K-Number: K203288 · 2021-10-05

ApplicantCala Health, Inc.
Decision Date2021-10-05
Product CodeQBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cala Trio is a medical device manufactured by Cala Health, Inc.. It received FDA 510(k) clearance on 2021-10-05 under approval number K203288. 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 Trio?

Cala Trio is a medical device that received FDA 510(k) clearance on 2021-10-05. It is manufactured by Cala Health, Inc.. The 510(k) number is K203288.

When was Cala Trio approved by the FDA?

Cala Trio received FDA 510(k) clearance on 2021-10-05, under approval number K203288.

What company makes Cala Trio?

Cala Trio is manufactured by Cala Health, Inc..

What is the FDA product code for Cala Trio?

The FDA product code for Cala Trio is QBC.

Other Devices by Cala Health, Inc.

K182706External upper limb tremor stimulator DEN170028Cala ONE K222237Cala kIQ K242259Cala kIQ K243848Cala kIQ K253587Cala kIQ Plus

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Related Devices (Code: QBC)

K182706External upper limb tremor stimulatorCala Health, Inc. DEN170028Cala ONECala Health, Inc. K222237Cala kIQCala Health, Inc. K242259Cala kIQCala Health, Inc. K250096Felix NeuroAI SystemFasikl Incorporated K243848Cala kIQCala Health, Inc.

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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