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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 K121642
Device Name WIZARD 230 NASAL PILOW MASK
Original Applicant
APEX MEDICAL CORP.
no. 9, minsheng street
tucheng city, taipei county,  TW 236
Original Contact frank lin
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/04/2012
Decision Date 06/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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