Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K073242 |
Device Name |
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 |
Applicant |
DELPHI MEDICAL SYSTEMS |
5725 DELPHI DRIVE |
TROY,
MI
48098
|
|
Applicant Contact |
GILBERT ROQUE |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 11/19/2007 |
Decision Date | 01/03/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|