Multichannel electrocardiograph, interpretive, home-use

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
19-07-2021

可用日期:

Quintessa Holdings Pty Ltd

类:

Class IIa

厂商:

Coala-Life AB Riddargarton 18, Stockholm, 11451 Sweden

治疗领域:

62641 - Multichannel electrocardiograph, interpretive, home-use

疗效迹象:

The product is a small hand-held device that is pressed against the chest for simultaneous recordings of ECG and heart sounds through electrodes and a stethoscope membrane. It is intended for use by healthcare professionals or individuals with known or suspected heart conditions and health conscious individuals. It is not intended for use for vital monitoring as in intensive care.

授权状态:

A

授权日期:

2021-05-18