510(k) K201002

Safey Pocket Spirometer by Safey Medical Devices Pvt, Ltd. — Product Code BZG

K201002 is an FDA 510(k) premarket notification submitted by Safey Medical Devices Pvt, Ltd. for the device "Safey Pocket Spirometer". The FDA issued a decision of Substantially Equivalent on July 30, 2020. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Safey Medical Devices Pvt, Ltd. has at least 1 other 510(k) clearance on record.