Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K161676 |
Device Name |
Q13 SPIROLYSER® |
Applicant |
FIM MEDICAL |
51 RUE PRIMAT CS 60194 |
Villeurbanne Cedex , Rhone,
FR
69625
|
|
Applicant Contact |
LIZA PERRAT |
Correspondent |
KAMM & ASSOCIATES |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 06/17/2016 |
Decision Date | 10/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|