Q'apel Medical, Inc. - March 8, 2022
Issue Date
Mar 08, 2022
Region
Pacific
Category
Device
$117.00
Contact Name
Kenneth A. Peartree
Contact Title
Chief Operating Officer
Address 1
46708 Lakeview Blvd.
City
Fremont
State
CA
Zip/Postal Code
94538-6529
Country
United States
Inspection Range
Feb 04, 2022 - Mar 08, 2022
Pages
4
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information 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): Maida Henesian