Device Classification Name |
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
|
510(k) Number |
K960593 |
Device Name |
SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 |
Applicant |
ARADIGM CORP. |
26219 EDEN LANDING RD. |
HAYWARD,
CA
94545
|
|
Applicant Contact |
DIANE JACHINOWSKI |
Correspondent |
ARADIGM CORP. |
26219 EDEN LANDING RD. |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
DIANE JACHINOWSKI |
Regulation Number | 868.5640
|
Classification Product Code |
|
Date Received | 02/12/1996 |
Decision Date | 05/10/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|