510(k) K963064

ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM by Laborie Medical Tech Corp. — Product Code FFX

K963064 is an FDA 510(k) premarket notification submitted by Laborie Medical Tech Corp. for the device "ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM". The FDA issued a decision of Substantially Equivalent on June 5, 1997. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Laborie Medical Tech Corp. has at least 5 other 510(k) clearances on record.