Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K094003 |
Device Name |
REVIVATOR |
Applicant |
HERSILL, S.L. |
PUERTO DE NAVACERRADA, 3 |
MOSTOLES ( MADRID),
ES
28935
|
|
Applicant Contact |
ANA MARIA ROMERO |
Correspondent |
HERSILL, S.L. |
PUERTO DE NAVACERRADA, 3 |
MOSTOLES ( MADRID),
ES
28935
|
|
Correspondent Contact |
ANA MARIA ROMERO |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 12/28/2009 |
Decision Date | 09/17/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|