510(k) K181583

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 by Flexicare Medical Limited. — Product Code BTM

K181583 is an FDA 510(k) premarket notification submitted by Flexicare Medical Limited. for the device "Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20". The FDA issued a decision of Substantially Equivalent on December 7, 2018. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Flexicare Medical Limited. has at least 7 other 510(k) clearances on record.