Device Classification Name |
spirometer, therapeutic (incentive)
|
510(k) Number |
K994074 |
Device Name |
TRI-BALL |
Applicant |
LEVENTON, S.A. |
POLIGONO CAN SUYER, 11 |
SANT ANDREU DE LA BARCA |
BARCELONA,
ES
08740
|
|
Applicant Contact |
JOAQUIM SORIANO |
Correspondent |
LEVENTON, S.A. |
POLIGONO CAN SUYER, 11 |
SANT ANDREU DE LA BARCA |
BARCELONA,
ES
08740
|
|
Correspondent Contact |
JOAQUIM SORIANO |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 12/02/1999 |
Decision Date | 06/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|