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SpiroLink

Guangzhou Red Elephant Medical Technology Co.,Ltd · Model B1 · UDI-DI 06970397220012

BZH
1
510(k) clearances
34
Adverse events
0
Recalls
41
Facilities

Description

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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.