510(k) K132668

IOB DISPOSABLE SPECULUM by Iob Medical, Inc. — Product Code HIB

K132668 is an FDA 510(k) premarket notification submitted by Iob Medical, Inc. for the device "IOB DISPOSABLE SPECULUM". The FDA issued a decision of Substantially Equivalent on January 17, 2014. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Iob Medical, Inc. has at least 6 other 510(k) clearances on record.