510(k) K913474

RESPIRE DISPOSABLE PULMONARY RESUSCITATOR by Med-Tek Innovations, Inc. — Product Code BTM

K913474 is an FDA 510(k) premarket notification submitted by Med-Tek Innovations, Inc. for the device "RESPIRE DISPOSABLE PULMONARY RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on February 3, 1993. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Med-Tek Innovations, Inc. has at least 2 other 510(k) clearances on record.