510(k) K121623

BIPAP A 40 VENTILATORY SUPPORT SYSTEM by Respironics, Inc. — Product Code MNT

K121623 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "BIPAP A 40 VENTILATORY SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 14, 2012. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Respironics, Inc. has at least 10 other 510(k) clearances on record.