Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K121531 |
Device Name |
A&J 5L POCA SERIES OXYGEN CONCENTRATOR |
Applicant |
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. |
3 SHENGHUI SOUTH ROAD |
NANTOU TOWN, ZHONGSHAN CITY |
GUANGDONG,
CN
|
|
Applicant Contact |
JUNHONG AN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 05/24/2012 |
Decision Date | 07/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|