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 couch, radiation therapy, powered
510(k) Number K120916
Device Name QFIX RADIOTHERAPY CHAIR
Applicant
WFR/AQUAPLAST CORP.
440 CHURCH ROAD
Avondale,  PA  19311
Applicant Contact TIM WADE
Correspondent
WFR/AQUAPLAST CORP.
440 CHURCH ROAD
Avondale,  PA  19311
Correspondent Contact TIM WADE
Regulation Number892.5770
Classification Product Code
JAI  
Date Received03/27/2012
Decision Date 06/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-