Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K042455 |
Device Name |
DEVILBISS NASAL CPAP MASK, 9354 SERIES |
Applicant |
SUNRISE MEDICAL |
100 DEVILBISS DR. |
SOMERSET,
PA
15501
|
|
Applicant Contact |
ALLAN JONES |
Correspondent |
SUNRISE MEDICAL |
100 DEVILBISS DR. |
SOMERSET,
PA
15501
|
|
Correspondent Contact |
ALLAN JONES |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 09/10/2004 |
Decision Date | 01/14/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|