510(k) K965187

SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD by Sparta Surgical Corp. — Product Code GZJ

K965187 is an FDA 510(k) premarket notification submitted by Sparta Surgical Corp. for the device "SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD". The FDA issued a decision of Substantially Equivalent on August 1, 1997. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Sparta Surgical Corp. has at least 6 other 510(k) clearances on record.