| Device Classification Name |
Spirometer, Diagnostic
|
| 510(k) Number |
K932936 |
| Device Name |
L.A.P. II SPRIOMETRY SYSTEM |
| Applicant |
| Allied Healthcare Products, Inc. |
| 1720 Sublette Ave. |
|
Saint Louis,
MO
63110
|
|
| Applicant Contact |
TIM DAVIS |
| Correspondent |
| Allied Healthcare Products, Inc. |
| 1720 Sublette Ave. |
|
Saint Louis,
MO
63110
|
|
| Correspondent Contact |
TIM DAVIS |
| Regulation Number | 868.1840 |
| Classification Product Code |
|
| Date Received | 06/16/1993 |
| Decision Date | 02/10/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|