Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K033939 |
Device Name |
FLOSENSE II, MODEL 29-8040 |
Applicant |
SDI DIAGNOSTICS, INC. |
10 HAMPDEN DR. |
EASTON,
MA
02375
|
|
Applicant Contact |
MICHAEL J BOYLE |
Correspondent |
SDI DIAGNOSTICS, INC. |
10 HAMPDEN DR. |
EASTON,
MA
02375
|
|
Correspondent Contact |
MICHAEL J BOYLE |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 12/15/2003 |
Decision Date | 01/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|