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FDA 510(k)

Coala Heart Monitor

K-Number: K212163 · 2022-04-14

ApplicantCoala Life AB
Decision Date2022-04-14
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Coala Heart Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Coala Life AB. It received FDA 510(k) clearance on 2022-04-14 under 510(k) number K212163. The device is classified under product code DPS. It was reviewed by the CV advisory panel. 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 2022-04-14. The listed applicant is Coala Life AB. The 510(k) number is K212163.

When did Coala Heart Monitor receive FDA 510(k) clearance?

Coala Heart Monitor received FDA 510(k) clearance on 2022-04-14, under 510(k) number K212163.

Who is the listed applicant for Coala Heart Monitor?

The FDA 510(k) record lists Coala Life AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coala Heart Monitor?

The FDA product code for Coala Heart Monitor is DPS.

Other records listing Coala Life AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182040Coala Heart Monitor

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, 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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