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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 K071608
Device Name A&J POCA01 OXYGEN CONCENTRATOR
Applicant
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
3 SHENGHUI SOUTH ROAD
NANTOU TOWN, ZHONGSHAN CITY
GUANGDONG,  CN
Applicant Contact POLO CHEN
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MICHELLE S LEE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/12/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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