BM.IRIS

BM.IRIS is the device name listed in this FDA 510(k) record. The listed applicant is Bluecore Co., Ltd.. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171648. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.