510(k) K910983

IV 1000 INSUFFLATOR RAPID FLOW by M.D. Engineering, Inc. — Product Code HIF

K910983 is an FDA 510(k) premarket notification submitted by M.D. Engineering, Inc. for the device "IV 1000 INSUFFLATOR RAPID FLOW". The FDA issued a decision of Substantially Equivalent on December 9, 1991. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. M.D. Engineering, Inc. has at least 3 other 510(k) clearances on record.