510(k) K880450

RESUSCI PATIENT FACE SHIELD by Laerdal Medical Corp. — Product Code BTM

K880450 is an FDA 510(k) premarket notification submitted by Laerdal Medical Corp. for the device "RESUSCI PATIENT FACE SHIELD". The FDA issued a decision of Substantially Equivalent on March 4, 1988. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Laerdal Medical Corp. has at least 10 other 510(k) clearances on record.