1032390

Sonablate Corp. — FEI 3007126306

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 29, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Charlotte, NC (United States)

Citations

IDCFRDescription
311821 CFR 820.75(a)Documentation
331021 CFR 820.120(b)DHR documentation of label release {see also 820.184}
333121 CFR 820.181DMR - not or inadequately maintained