510(k) K970145

PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) by Biosearch Medical Products, Inc. — Product Code HIR

K970145 is an FDA 510(k) premarket notification submitted by Biosearch Medical Products, Inc. for the device "PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)". The FDA issued a decision of Substantially Equivalent on August 11, 1997. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Biosearch Medical Products, Inc. has at least 10 other 510(k) clearances on record.