Device Classification Name |
spirometer, therapeutic (incentive)
|
510(k) Number |
K160837 |
Device Name |
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM |
Applicant |
MEDINET SRL |
VIA LONDONIO, 12 |
MILANO,
IT
20154
|
|
Applicant Contact |
STEFANO BERNUCCI |
Correspondent |
ISEMED SRL |
VIA A.BONETTI 3/A |
IMOLA,
IT
40026
|
|
Correspondent Contact |
MAURIZIO PANTALEONI |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 03/25/2016 |
Decision Date | 02/23/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|