Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K010761 |
Device Name |
SPL-50 SPIROLYSER |
Applicant |
FIM MEDICAL |
30 RUE CAMILLE |
LYON,
FR
69003
|
|
Applicant Contact |
ERIC DEREI |
Correspondent |
FIM MEDICAL |
30 RUE CAMILLE |
LYON,
FR
69003
|
|
Correspondent Contact |
ERIC DEREI |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 03/13/2001 |
Decision Date | 03/05/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|