Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K905520 |
Device Name |
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION |
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 | 12/07/1990 |
Decision Date | 04/26/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|