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1059092

Innovative Medical Equipment — FEI 3007353136

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Beachwood, OH (United States)

Facility

Other inspections at this facility

  • 1164125 (VAI Thu Mar 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 708678 (NAI Tue Feb 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 663430 (VAI Tue May 18 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate