510(k) K800222

MODEL 412 ELECTROFLUIDIC MANOMETER by Med-Tek Corp. — Product Code DXW

K800222 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "MODEL 412 ELECTROFLUIDIC MANOMETER". The FDA issued a decision of Substantially Equivalent on February 29, 1980. The device falls under product code DXW (System, Phonocatheter, Intracavitary), a Class II device regulated under 21 CFR 870.1270. Med-Tek Corp. has at least 10 other 510(k) clearances on record.