Infinite Biomedical Technologies - June 10, 2022
Issue Date
Jun 10, 2022
Region
Central
Category
Device
$117.00
Contact Name
Damini Agarwal
Contact Title
Director of Product Development
Address 1
8 Market Pl.
Address 2
Ste. 500
City
Baltimore
State
MD
Zip/Postal Code
21202-4264
Inspection Range
Jun 06, 2022 - Jun 10, 2022
Pages
7
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise 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 injmy if the malfunction were to recur.
Investigator(s): Jude C. Dike