Saluda Medical PTY Ltd. - June 6, 2019
Issue Date
Jun 06, 2019
Region
HQ
Category
Device
$117.00
Contact Name
Greg S. Plamondom
Contact Title
Chief Financial Officer
Address 1
Level 1, 407 Pacific Hwy.
City
Artarmon, New South Wales
Zip/Postal Code
2064
Country
Australia
Inspection Range
Jun 03, 2019 - Jun 06, 2019
Pages
4
First Observation
Changes to software used as part of production were not validated before approval and issuance.
Investigator(s): Edward E. Lockwood