DigiO2 International Co., Ltd. - July 10, 2014
Issue Date
Jul 10, 2014
Region
HQ
Category
Device
$117.00
Contact Name
Casper Chen
Contact Title
President and General Manager
Address 1
No. 582
Address 2
Kuo-Hwa Rd.
City
Miaoli
Zip/Postal Code
36055
Country
Taiwan
Inspection Range
Jul 07, 2014 - Jul 10, 2014
Pages
4
First Observation
The written MDR procedure does not include an internal system which provides for the timely and effective identification, communication, and evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Evelyn Taha