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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 K182394
Device Name WiZARD 310/320 Series CPAP Mask
Applicant
Apex Medical Corp.
No. 9 Min Sheng St. Tu-Cheng
New Taipei City,  TW 23679
Applicant Contact Frank Lin
Correspondent
Apex Medical Corp.
No. 9 Min Sheng St. Tu-Cheng
New Taipei City,  TW 23679
Correspondent Contact Frank Lin
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/04/2018
Decision Date 05/17/2019
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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