Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K071689 |
Device Name |
DEVILBISS INTELLIPAP MODEL DV 5 SERIES |
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 | 06/20/2007 |
Decision Date | 09/07/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|