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 Accelerator, Linear, Medical
510(k) Number K252174
Device Name AquaCast Mask
Applicant
Blessing Cathay Corporation
2f, # 310, Jianguo 1st Rd., Xinzhuang District
New Taipei City,  TW 242047
Applicant Contact Jerry Su
Correspondent
Blessing Cathay Corporation
2f, # 310, Jianguo 1st Rd., Xinzhuang District
New Taipei City,  TW 242047
Correspondent Contact Jerry Su
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/11/2025
Decision Date 09/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-