510(k) K182956

Puffin Lite Infant Resuscitation System by International Biomedical — Product Code BTL

K182956 is an FDA 510(k) premarket notification submitted by International Biomedical for the device "Puffin Lite Infant Resuscitation System". The FDA issued a decision of Substantially Equivalent on January 18, 2019. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. International Biomedical has at least 10 other 510(k) clearances on record.