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 K933613
Device Name 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER
Applicant
Bionix Development Corp.
5154 Enterprise Blvd.
Toledo,  OH  43612
Applicant Contact RICHARD A WASSERMAN
Correspondent
Bionix Development Corp.
5154 Enterprise Blvd.
Toledo,  OH  43612
Correspondent Contact RICHARD A WASSERMAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/19/1993
Decision Date 10/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-