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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number868.5440
Classification Product Code
CAW  
Date Received01/02/2009
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
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