510(k) K031740

VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES by Welch Allyn Protocol, Inc. — Product Code DQA

K031740 is an FDA 510(k) premarket notification submitted by Welch Allyn Protocol, Inc. for the device "VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES". The FDA issued a decision of Substantially Equivalent on August 26, 2003. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Welch Allyn Protocol, Inc. has at least 6 other 510(k) clearances on record.