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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 K193206
Device Name WiZARD 510 Nasal Mask
Applicant
Apex Medical Corp.
# 9, Min Sheng St., Tu-Cheng
New Taipei City,  TW 23679
Applicant Contact Chieh Yang
Correspondent
Apex Medical Corp.
# 9, Min Sheng St., Tu-Cheng
New Taipei City,  TW 23679
Correspondent Contact Chieh Yang
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/20/2019
Decision Date 10/29/2020
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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