Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K163485 |
Device Name |
SmartTouch |
Applicant |
Adherium (NZ) Ltd |
Level 2, 204 Quay Street |
Auckland,
NZ
1010
|
|
Applicant Contact |
CHRIS MANDER |
Correspondent |
Adherium (NZ) Ltd |
Level 2, 204 Quay Street |
Auckland,
NZ
1010
|
|
Correspondent Contact |
CHRIS MANDER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/12/2016 |
Decision Date | 08/30/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|