State Street / 2V1 K122058 Trade / Welch Allyn Inc. / / /
Event
FDA Phase / / /
IndustryTerm
subject device / noninvasive blood pressure measurement systems / manufacturing practice requirements / neonatal applications / marketed predicate devices / concerning your device / manufacturing practice / /
Organization
Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / 441vision Sign-off Division of Cardiovascular Devices / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /
Person
Silver Spring / Kevin Crossen / / /
Position
physician / General / Director Regulatory Affairs / Director Regulatory Affairs Phone / /
510(k)Stummnar [As described in 21 CFR[removed]Submitted by: Welch Allyn Inc.