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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K122610
Device Name PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
Applicant
SEN MU TECHNOLOGY CO., LTD.
NO. 15-2, LANE 26, MINCYUAN 1SR RD
LINGYA DISTRICT
KAOHSIUNG CITY,  TW 802
Applicant Contact MING-YIE JN, PH.D.
Correspondent
SEN MU TECHNOLOGY CO., LTD.
NO. 15-2, LANE 26, MINCYUAN 1SR RD
LINGYA DISTRICT
KAOHSIUNG CITY,  TW 802
Correspondent Contact MING-YIE JN, PH.D.
Regulation Number868.5965
Classification Product Code
BYE  
Date Received08/27/2012
Decision Date 08/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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