Device Classification Name |
Holding Chambers, Direct Patient Interface
|
510(k) Number |
K143615 |
Device Name |
Antistatic Compact Space Chamber |
Applicant |
MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED |
7/56 SMITH ROAD |
SPRINGVALE,
AU
3171
|
|
Applicant Contact |
MAGGIE OH |
Correspondent |
MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED |
7/56 SMITH ROAD |
SPRINGVALE,
AU
3171
|
|
Correspondent Contact |
MAGGIE OH |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/19/2014 |
Decision Date | 01/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|