Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K083559 |
Device Name |
YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B |
Applicant |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMAN F ESTRIN |
Correspondent |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
9109 COPENHAVER DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMAN F ESTRIN |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 12/02/2008 |
Decision Date | 09/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|