Device Classification Name |
device, positive pressure breathing, intermittent
|
510(k) Number |
K140605 |
Device Name |
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC |
Applicant |
DIMA ITALIA SRL |
via Coriolano Vighi, 29 |
Bologna,
IT
40133
|
|
Applicant Contact |
DARIO BASCIU |
Correspondent |
DIMA ITALIA SRL |
via Coriolano Vighi, 29 |
Bologna,
IT
40133
|
|
Correspondent Contact |
DARIO BASCIU |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/10/2014 |
Decision Date | 10/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|