FDA 510(k)

Coala Heart Monitor

K-Number: K182040 · 2019-02-08

Decision Date2019-02-08

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Coala Heart Monitor is a medical device manufactured by Coala Life AB. It received FDA 510(k) clearance on 2019-02-08 under approval number K182040. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Coala Heart Monitor?

Coala Heart Monitor is a medical device that received FDA 510(k) clearance on 2019-02-08. It is manufactured by Coala Life AB. The 510(k) number is K182040.

When was Coala Heart Monitor approved by the FDA?

Coala Heart Monitor received FDA 510(k) clearance on 2019-02-08, under approval number K182040.

What company makes Coala Heart Monitor?

Coala Heart Monitor is manufactured by Coala Life AB.

What is the FDA product code for Coala Heart Monitor?

The FDA product code for Coala Heart Monitor is DXH. This falls under the Hematology category.

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Other Devices by Coala Life AB

K212163Coala Heart Monitor

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Official Source

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