Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K143035 |
Device Name |
Flight 60 Ventilator |
Applicant |
FLIGHT MEDICAL INNOVATIONS LTD. |
13 HAMELACHA STREET |
NORTH INDUSTRIAL PARK |
LOD,
IL
71520
|
|
Applicant Contact |
Yanir Shaked |
Correspondent |
MJRAC |
1208-12 Rockford Rd, |
Toronto,
CA
M2R 3A2
|
|
Correspondent Contact |
Bosmat Friedman |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/22/2014 |
Decision Date | 03/30/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|