Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K133951 |
Device Name |
SMARTTOUCH |
Applicant |
NEXUS6, LTD. |
8 COMMERCE STREET |
SUITE 205 |
AUCKLAND,
NZ
1010
|
|
Applicant Contact |
GARTH SUTHERLAND |
Correspondent |
NEXUS6, LTD. |
8 COMMERCE STREET |
SUITE 205 |
AUCKLAND,
NZ
1010
|
|
Correspondent Contact |
GARTH SUTHERLAND |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/23/2013 |
Decision Date | 04/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|