510(k) K014294

MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 by Medical Data Electronics — Product Code DQA

K014294 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414". The FDA issued a decision of Substantially Equivalent on January 25, 2002. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Medical Data Electronics has at least 10 other 510(k) clearances on record.