510(k) K970756

MERCURY MEDICAL REUSABLE CPR BAG by Mercury Medical — Product Code BTM

K970756 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY MEDICAL REUSABLE CPR BAG". The FDA issued a decision of Substantially Equivalent on October 31, 1997. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Mercury Medical has at least 10 other 510(k) clearances on record.