Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K061571 |
Device Name |
ASTRA 300 |
Applicant |
SDI DIAGNOSTICS, INC. |
10 HAMPDEN DR. |
EASTON,
MA
02375
|
|
Applicant Contact |
COSIMO CARIOLO |
Correspondent |
SDI DIAGNOSTICS, INC. |
10 HAMPDEN DR. |
EASTON,
MA
02375
|
|
Correspondent Contact |
COSIMO CARIOLO |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 06/06/2006 |
Decision Date | 01/31/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|