510(k) K960492

SI CONTROLLER MODEL SI 500 by I.C Medical, Inc. — Product Code BTA

K960492 is an FDA 510(k) premarket notification submitted by I.C Medical, Inc. for the device "SI CONTROLLER MODEL SI 500". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. I.C Medical, Inc. has at least 10 other 510(k) clearances on record.