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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K041823
Device Name PIONEER U121 SERIES CPAP
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG,  TW 407
Applicant Contact STEVE CHAO
Correspondent
MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG,  TW 407
Correspondent Contact STEVE CHAO
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/06/2004
Decision Date 05/10/2005
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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