Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K090007 |
Device Name |
JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 |
Applicant |
DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. |
NO.89 SHUANGFENG ROAD, |
JIEPAI TOWN |
DANYANG CITY,JIANGSU PROVINCE,
CN
212300
|
|
Applicant Contact |
QING WANG |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 01/02/2009 |
Decision Date | 07/24/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|