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Respire Medical Holdings, LLC - Aug. 15, 2019

Issue Date

Aug 15, 2019

Region

Northeast

Category

Device
$117.00

Respire Medical Holdings, LLC

Contact Name

David Walton

Contact Title

CEO

Form483 Address 1

18 Bridge St.

Form483 Address 2

Ste. 3J

Form483 City

Brooklyn

Form483 State

NY

Form483 Postal

11201-1107

Form483 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