510(k) K251777

MESI mTABLET SPIRO by Mesi D.O.O. — Product Code BZG

K251777 is an FDA 510(k) premarket notification submitted by Mesi D.O.O. for the device "MESI mTABLET SPIRO". The FDA issued a decision of Substantially Equivalent on March 2, 2026. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840.