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 System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K854953
Device Name DIAMED MODELS 600, 900, 960, 964
Applicant
Diamed Division Ill. Tool Works, Inc.
23322 S. Pt.e Dr., Suite E
Laguna Hills,  CA  92653
Applicant Contact ROBERT J BRASHER
Correspondent
Diamed Division Ill. Tool Works, Inc.
23322 S. Pt.e Dr., Suite E
Laguna Hills,  CA  92653
Correspondent Contact ROBERT J BRASHER
Regulation Number892.1650
Classification Product Code
JAA  
Date Received12/10/1985
Decision Date 04/22/1986
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
-
-