| Device Classification Name |
Monitor, Breathing Frequency
|
| 510(k) Number |
K924875 |
| Device Name |
MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS |
| Applicant |
| Synectics-Dantec |
| 1425 Greenway Dr. |
| Suite 600 |
|
Irving,
TX
75038
|
|
| Applicant Contact |
ANNA PETTERSSON |
| Correspondent |
| Synectics-Dantec |
| 1425 Greenway Dr. |
| Suite 600 |
|
Irving,
TX
75038
|
|
| Correspondent Contact |
ANNA PETTERSSON |
| Regulation Number | 868.2375 |
| Classification Product Code |
|
| Date Received | 09/14/1992 |
| Decision Date | 06/30/1994 |
| Decision |
SE SUBJECT TO TRACKING REG
(ST) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|