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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 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 Number868.5440
Classification Product Code
CAW  
Date Received05/24/2012
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
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