510(k) K071185

MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE by Ambu A/S — Product Code GXZ

K071185 is an FDA 510(k) premarket notification submitted by Ambu A/S for the device "MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 30, 2007. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Ambu A/S has at least 10 other 510(k) clearances on record.