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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
Original Applicant
SEN MU TECHNOLOGY CO., LTD.
no. 15-2, lane 26, mincyuan 1sr rd
lingya district
kaohsiung city,  TW 802
Original 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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