Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name ventilator, non-continuous (respirator)
510(K) Number K121642
Device Name WIZARD 230 NASAL PILOW MASK
Applicant
APEX MEDICAL CORP.
no. 9, minsheng street
tucheng city, taipei county, 
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
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-