Outset Medical, Inc. - Feb. 10, 2023
Issue Date
Feb 10, 2023
Region
Pacific
Category
Device
$117.00
Contact Name
Leslie L. Trigg
Contact Title
CEO and Chair
Address 1
3052 Orchard Dr.
City
San Jose
State
CA
Zip/Postal Code
95134-2011
Inspection Range
Jan 17, 2023 - Feb 10, 2023
Pages
5
First Observation
An MDR report was not submitted within 30 days ofreceiving or otherwise becoming aware of information. that reasonably suggests that a marketed device may have caused or contributed to a death or senous injury.
Investigator(s): Suzanne M. Healy, Maida Henesian, and Anil K. Kochhar