Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K973456 |
Device Name |
SPIROBANK PORTABLE PC BASED SPIROMETER |
Applicant |
FUTUREMED AMERICA, INC. |
15700 DEVONSHIRE ST. |
GRANADA HILLS,
CA
91344 -7225
|
|
Applicant Contact |
MICHAEL DAVIDSON |
Correspondent |
FUTUREMED AMERICA, INC. |
15700 DEVONSHIRE ST. |
GRANADA HILLS,
CA
91344 -7225
|
|
Correspondent Contact |
MICHAEL DAVIDSON |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 09/11/1997 |
Decision Date | 07/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|