Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K171411 |
Device Name |
IRRIS (Infra-Red-Red Intubation System) |
Applicant |
A.R Guide In Medical Ltd. |
13 Wadi El Haj |
Nazareth,
IL
17111
|
|
Applicant Contact |
Ariel Shrem |
Correspondent |
MedicSense, USA |
291 Hillside Avenue |
Somerset,
MA
02726
|
|
Correspondent Contact |
George J. Hattub |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 05/15/2017 |
Decision Date | 01/12/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|