Insightra Medical, Inc. - Feb. 24, 2015
Issue Date
Feb 24, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Wayne A. Noda
Contact Title
Chief Technical Officer
Address 1
9200 Irvine Center Dr.
Address 2
Ste. 200
City
Irvine
State
CA
Zip/Postal Code
92618-5600
Country
United States
Inspection Range
Feb 19, 2015 - Feb 24, 2015
Pages
3
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): Kimberly M. Lichter