510(k) K935477

AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD by Datex Division Instrumentarium Corp. — Product Code CCK

K935477 is an FDA 510(k) premarket notification submitted by Datex Division Instrumentarium Corp. for the device "AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD". The FDA issued a decision of Substantially Equivalent on August 1, 1994. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Datex Division Instrumentarium Corp. has at least 10 other 510(k) clearances on record.