Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K152438 |
Device Name |
ETView VivaSight-SL (TVT) system |
Applicant |
ETVIEW LTD. |
M.P MISGAV |
MISGAV BUSINESS PARK,
IL
201790
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
QSITE |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 08/27/2015 |
Decision Date | 02/25/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|