Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K082209 |
Device Name |
DEVILBISS DV5M SMARTLINK SYSTEM |
Applicant |
SUNRISE MEDICAL |
100 DEVILBISS DR. |
SOMERSET,
PA
15501
|
|
Applicant Contact |
JOSEPH E OLSAVSKY |
Correspondent |
SUNRISE MEDICAL |
100 DEVILBISS DR. |
SOMERSET,
PA
15501
|
|
Correspondent Contact |
JOSEPH E OLSAVSKY |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 08/05/2008 |
Decision Date | 10/28/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|