Guangzhou Red Elephant Medical Technology Co.,Ltd

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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

Meter, Peak Flow, Spirometry (BZH) (1)

Premarket Exempt

Clear

SpiroLink - 06970397220012 Catalog Number :

Device Description : This device is intended to monitor a patient’s Peak Expiratory Flow (PEF) and Fo This device is intended to monitor a patient’s Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.

Device Class : 2

Duns Number: 544581675

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

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