510(k) K844689

ENDOSCOPIC MANUAL AIR INSUFFLATOR by Jayco Pharmaceuticals — Product Code FCX

K844689 is an FDA 510(k) premarket notification submitted by Jayco Pharmaceuticals for the device "ENDOSCOPIC MANUAL AIR INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on January 2, 1985. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Jayco Pharmaceuticals has at least 8 other 510(k) clearances on record.