510(k) K862547

MECHANICAL INFLATION DEVICE by American Edwards Laboratories — Product Code DXT

K862547 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "MECHANICAL INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on September 3, 1986. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. American Edwards Laboratories has at least 10 other 510(k) clearances on record.