| Device Classification Name |
Ventilatory Effort Recorder
|
| 510(k) Number |
K992322 |
| Device Name |
SNAP MODEL 5 |
| Applicant |
| Snap Laboratories, LLC |
| 3633 W. Lake Ave., Suite 406 |
|
Glenview,
IL
60025
|
|
| Applicant Contact |
GIL RAVIV |
| Correspondent |
| Snap Laboratories, LLC |
| 3633 W. Lake Ave., Suite 406 |
|
Glenview,
IL
60025
|
|
| Correspondent Contact |
GIL RAVIV |
| Regulation Number | 868.2375 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 07/12/1999 |
| Decision Date | 02/02/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|