Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K993199 |
Device Name |
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER |
Applicant |
FERRARIS MEDICAL, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
FERRARIS MEDICAL, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/23/1999 |
Decision Date | 03/28/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|