Machine for diagnosing sleep apnea - Vietnam Registration 240001587/PCBB-HCM
Access comprehensive regulatory information for Machine for diagnosing sleep apnea in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loแบกi B medical device is registered under number 240001587/PCBB-HCM and manufactured by ResMed Pty Ltd. The authorized representative in Vietnam is CรNG TY TNHH ASIA ACTUAL VIETNAM.
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Device Details
Registration Details
240001587/PCBB-HCM
000.00.19.H29-240723-0004
ApneaLink Air
Technical Details
The ApneaLink Air device is intended for Healthcare Professionals (HCP) to be able to support the diagnosis of sleep disordered breathing in adult patients. ApneaLink Air records the following data: the patient's nasal airflow, snoring sounds, blood oxygen saturation, and respiratory efforts during sleep. The device uses these recordings to generate a report for the HCP to support the diagnosis of sleep disordered breathing or for additional clinical investigation, if possible. The device is designed to be used at home and in the hospital under the guidance of the HCP.
Dates and Status
Jul 26, 2024