Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K071397 |
Device Name |
DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 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 | 868.5440
|
Classification Product Code |
|
Date Received | 05/21/2007 |
Decision Date | 10/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|