510(k) K904396

SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM by Simplex Medical Systems, Inc. — Product Code BZQ

K904396 is an FDA 510(k) premarket notification submitted by Simplex Medical Systems, Inc. for the device "SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 5, 1991. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Simplex Medical Systems, Inc. has at least 2 other 510(k) clearances on record.