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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
Model POCA01B, POCA03, POCA04, POCA05, POCA06
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, 
Contact junhong an
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/24/2012
Decision Date 07/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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