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1167843

Draeger Medical Systems, Inc. — FEI 3005783425

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 21, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Andover, MA (United States)

Facility

Other inspections at this facility

  • 1256505 (NAI Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109645 (NAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827184 (VAI Fri Apr 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 635977 (NAI Fri Dec 11 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
367721 CFR 820.30(g)Design validation - software validation not performed
73221 CFR 803.50(a)(2)Individual Report of Malfunction