Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K020932 |
Device Name |
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR |
Applicant |
SUNRISE MEDICAL |
100 DEVILBISS DR. |
SOMERSET,
PA
15501
|
|
Applicant Contact |
RAY HOFFMAN |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Regulation Number | 868.5630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/22/2002 |
Decision Date | 06/28/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|