510(k) K792118

AIR-SHIELDS RESUSCITATORS by Narco Air-Shields — Product Code BTM

K792118 is an FDA 510(k) premarket notification submitted by Narco Air-Shields for the device "AIR-SHIELDS RESUSCITATORS". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Narco Air-Shields has at least 10 other 510(k) clearances on record.