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) | 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, Continuous, Facility Use
510(k) Number K251888
Device Name VPAP Pediatric Face Mask
Applicant
Hsiner Co., Ltd.
#312, Jhongshan Rd., Shengang Dist.
Taichung City,  TW 429
Applicant Contact Sandy Chang
Correspondent
Voler Biotech Consulting CO., Ltd.
6f.-17, # 14, Ln. 609, Sec. 5, Chongxin Rd.,
Sanchong Dist.
New Taipei City,  TW 241407
Correspondent Contact Yvonne Chen
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/20/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-