Respironics California, LLC - Sept. 10, 2021
Issue Date
Sep 10, 2021
Region
Pacific
Category
Device
$117.00
Contact Name
Richard Kelly
Contact Title
Senior Director R&D/ Site Lead
Address 1
2271 Cosmos Ct.
City
Carlsbad
State
CA
Zip/Postal Code
92011-1517
Country
United States
Inspection Range
Aug 30, 2021 - Sep 10, 2021
Pages
6
First Observation
Procedures for design validation have not been adequately established.
Investigator(s): Daniel J. Lahar