Device Classification Name |
Calculator, Pulmonary Function Interpretor (Diagnostic)
|
510(k) Number |
K090863 |
Device Name |
PERSONAL WHEEZOMETER |
Applicant |
KARMELSONIX |
31 HAAVODA ST. |
BINYAMINA,
IL
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
KARMELSONIX |
31 HAAVODA ST. |
BINYAMINA,
IL
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 868.1900
|
Classification Product Code |
|
Date Received | 03/30/2009 |
Decision Date | 09/21/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|