510(k) K061306

CO-1000 COLPOSCOPE, MULTIPLE by Gynex Corp. — Product Code HEX

K061306 is an FDA 510(k) premarket notification submitted by Gynex Corp. for the device "CO-1000 COLPOSCOPE, MULTIPLE". The FDA issued a decision of Substantially Equivalent on August 7, 2006. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Gynex Corp. has at least 4 other 510(k) clearances on record.