Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K984085 |
Device Name |
RITEFLO SPACER |
Applicant |
AEROMAX TECHNOLOGIES, INC. |
12020 S. WARNER/ELLIOT LOOP |
SUITE 124 |
PHOENIX,
AZ
85044
|
|
Applicant Contact |
ALLAN M WACHTER |
Correspondent |
AEROMAX TECHNOLOGIES, INC. |
12020 S. WARNER/ELLIOT LOOP |
SUITE 124 |
PHOENIX,
AZ
85044
|
|
Correspondent Contact |
ALLAN M WACHTER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 11/16/1998 |
Decision Date | 08/05/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|