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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.
# 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.
# 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
Predetermined Change
Control Plan Authorized		 No
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