INVOS monitoring system - PMDA ID 610015_30100BZX00181000_B_01_03
Access comprehensive regulatory information for INVOS monitoring system (INVOSモニタリングシステム) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 610015_30100BZX00181000_B_01_03 and manufactured by Covidien Japan Co., Ltd.. The device information was last updated on September 02, 2022.
This page provides complete registration details including device class (A2100), classification (brain oximeter / 脳オキシメータ), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.
This product is an auxiliary monitor that non-invasively measures the local mixed blood oxygen saturation in the brain or other biological tissue directly under the sensor. This product is intended for use in patients weighing 2.5 kg or more who may have low blood flow or ischemic conditions without blood flow. It is also intended for use as an auxiliary trend monitor of local mixed oxygen saturation in the brain or other biological tissue directly under any patient's sensor.
本品はセンサ直下の脳又はその他の生体組織における局所の混合血酸素飽和度を無侵襲で測定する補助的モニタである。本品は、低血流又は血流のない虚血状態のおそれがある体重2.5kg以上の患者への使用を意図している。また、あらゆる患者のセンサ直下の脳又はその他の生体組織における局所の混合血酸素飽和度の補助的なトレンドモニタとしての使用を意図している。