Coala-Life AB

Address:Kalsangsgrand 10b,Uppsala Stockholm,SE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (1)

Premarket Exempt

Clear

Coala Heart Monitor US Rx - 07350002700105 Catalog Number : N/A

Device Description : The Coala Heart Monitor is a medical device system that can be used by healthcar The Coala Heart Monitor is a medical device system that can be used by healthcareprofessionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings.Persons with known or suspected heart conditions can use the Coala Heart Monitor to recordECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrialfibrillation (AF) and to make these recordings available to their physician.

Device Class :

Duns Number: 351157594

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

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