Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K082038 |
Device Name |
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V |
Applicant |
CLARUS MEDICAL, LLC. |
1000 BOONE AVE. NORTH |
SUITE 300 |
MINNEAPOLIS,
MN
55427
|
|
Applicant Contact |
THOMAS BARTHEL |
Correspondent |
CLARUS MEDICAL, LLC. |
1000 BOONE AVE. NORTH |
SUITE 300 |
MINNEAPOLIS,
MN
55427
|
|
Correspondent Contact |
THOMAS BARTHEL |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 07/17/2008 |
Decision Date | 04/28/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|