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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 K102245
Device Name CARE ZY5BA OXYGEN CONCENTRATOR
Applicant
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
KEJIMAN 12 ROAD, HI-TEC IND PK
HUATONGWEI BLDG
NANSHAN, SHENZHEN,  CN 518057
Applicant Contact KATHY GUO
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/09/2010
Decision Date 11/09/2010
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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