Electromed, Inc. - Jan. 13, 2023
Issue Date
Jan 13, 2023
Region
Central
Category
Device
$117.00
Contact Name
Kathleen S. Skarvan
Contact Title
President and CEO
Address 1
502 6th Ave. NW
City
New Prague
State
MN
Zip/Postal Code
56071-1134
Inspection Range
Jan 09, 2023 - Jan 13, 2023
Pages
4
First Observation
An MDR report was not submitted within 30 days of receiving or ottherwise becoming aware of infonnation that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Albert L. Nguyen