510(k) K021681

MICROPAQ, MODELS 402, 404 by Welch Allyn Protocol, Inc. — Product Code DRT

K021681 is an FDA 510(k) premarket notification submitted by Welch Allyn Protocol, Inc. for the device "MICROPAQ, MODELS 402, 404". The FDA issued a decision of Substantially Equivalent on July 23, 2002. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Welch Allyn Protocol, Inc. has at least 6 other 510(k) clearances on record.