Zyno Medical, LLC - Dec. 15, 2017
Issue Date
Dec 15, 2017
Region
Northeast
Category
Device
$117.00
Contact Name
Chaoyoung Lee
Contact Title
President
Address 1
177 Pine St.
City
Natick
State
MA
Zip/Postal Code
01760-1029
Country
United States
Inspection Range
Dec 05, 2017 - Dec 15, 2017
Pages
2
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): Suzanne M. Healy