FDA 510(k) Application Details - K102245

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K102245
Device Name Generator, Oxygen, Portable
Applicant FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
KEJIMAN 12 ROAD, HI-TEC IND PK
HUATONGWEI BLDG
NANSHAN, SHENZHEN 518057 CN
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Contact KATHY GUO
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 08/09/2010
Decision Date 11/09/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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