SonarMed, Inc. - March 29, 2019
Issue Date
Mar 29, 2019
Region
Central
Category
Device
$117.00
Contact Name
Laura L. Lyons
Contact Title
Vice President Compliance & Respiratory Care
Address 1
12220 N. Meridian St.
Address 2
Ste. 150
City
Carmel
State
IN
Zip/Postal Code
46032-6972
Country
United States
Inspection Range
Mar 26, 2019 - Mar 29, 2019
Pages
2
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Debara R. Reese