510(k) K160540

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM by Flexicare Medical Limited. — Product Code BZE

K160540 is an FDA 510(k) premarket notification submitted by Flexicare Medical Limited. for the device "FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 2016. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Flexicare Medical Limited. has at least 7 other 510(k) clearances on record.