Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K904625 |
Device Name |
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM |
Applicant |
SYNECTICS-DANTEC |
RENSTIENAS GATA 12, 5TR. |
S-116 28 STOCKHOLM |
SWEDEN,
SE
S-116 28
|
|
Applicant Contact |
ANNA PETTERSSON |
Correspondent |
SYNECTICS-DANTEC |
RENSTIENAS GATA 12, 5TR. |
S-116 28 STOCKHOLM |
SWEDEN,
SE
S-116 28
|
|
Correspondent Contact |
ANNA PETTERSSON |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 10/10/1990 |
Decision Date | 08/20/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|