510(k) K833397

TRI-MED 511 INFANT RESPIRATION MONITOR by Tri-Med, Inc. — Product Code CCK

K833397 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "TRI-MED 511 INFANT RESPIRATION MONITOR". The FDA issued a decision of Substantially Equivalent on Nov 28, 1983. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.