Respire Medical Holdings, LLC - Aug. 15, 2019
Issue Date
Aug 15, 2019
Region
Northeast
Category
Device
$117.00
Contact Name
David Walton
Contact Title
CEO
Address 1
18 Bridge St.
Address 2
Ste. 3J
City
Brooklyn
State
NY
Zip/Postal Code
11201-1107
Country
United States
Inspection Range
Jul 19, 2019 - Aug 15, 2019
Pages
10
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): Colin E. Tack