• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 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
-
-