510(k) K982733

OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE by The Olympus Optical Co. — Product Code ITX

K982733 is an FDA 510(k) premarket notification submitted by The Olympus Optical Co. for the device "OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE". The FDA issued a decision of Substantially Equivalent on October 28, 1998. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. The Olympus Optical Co. has at least 10 other 510(k) clearances on record.