Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K092263 |
Device Name |
ENDURAVENT-5 VENTILATOR |
Applicant |
PROVIDENCE GLOBAL MEDICAL, INC. |
4659 SOUTH, 2300 EAST #203 |
SALT LAKE CITY,
UT
84117
|
|
Applicant Contact |
HELEN REDD |
Correspondent |
PROVIDENCE GLOBAL MEDICAL, INC. |
4659 SOUTH, 2300 EAST #203 |
SALT LAKE CITY,
UT
84117
|
|
Correspondent Contact |
HELEN REDD |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 07/28/2009 |
Decision Date | 01/21/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|