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 K933614
Device Name PITUITARY BOARD
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
-
-