Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Coala Life AB. It received FDA 510(k) clearance on 2022-04-14 under approval 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. It is manufactured by Coala Life AB. The 510(k) number is K212163.

When was Coala Heart Monitor approved by the FDA?

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

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 DPS.

Related Clinical Trials

NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT05707806 Development and Validation of Learning and Decision-Making Tasks RECRUITING NCT04405583 The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING

Other Devices by Coala Life AB

K182040Coala Heart Monitor

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

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.

↑