510(k) K854976

RMI RESPIRATORY GATING SYSTEM MODEL 301 by Radiation Measurements, Inc. — Product Code IXO

K854976 is an FDA 510(k) premarket notification submitted by Radiation Measurements, Inc. for the device "RMI RESPIRATORY GATING SYSTEM MODEL 301". The FDA issued a decision of Substantially Equivalent on May 7, 1986. The device falls under product code IXO (Synchronizer, Ecg / Respirator, Radiographic), a Class I device regulated under 21 CFR 892.1970. Radiation Measurements, Inc. has at least 10 other 510(k) clearances on record.