Welch Allyn Protocol, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0633-2014Class IIThe Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indNovember 21, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K070204LINK TO ACUITY CLINICIAN NOTIFIERMarch 23, 2007
K063419MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )December 4, 2006
K033378VITAL SIGNS MONITOR, PROPAQ LTMarch 1, 2004
K031740VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIESAugust 26, 2003
K022453MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEMAugust 21, 2002
K021681MICROPAQ, MODELS 402, 404July 23, 2002
K012451PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246August 20, 2001