Health Care Technology - April 25, 2022
Issue Date
Apr 25, 2022
Region
Northeast
Category
Device
$117.00
Contact Name
Jenny M. Morey
Contact Title
Customer Service Manager
Address 1
200 Butterfield Dr.
City
Ashland
State
MA
Zip/Postal Code
01721-2060
Country
United States
Inspection Range
Apr 20, 2022 - Apr 25, 2022
Pages
5
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): James P. Finn