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, Image Processing, Radiological
510(k) Number K032555
Device Name 3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
Applicant
Totoku Electric Co., Ltd.
300 Oya , Ueda-Shi,
Nagano-Ken,  JP 386-0192
Applicant Contact MIKIO HASEGAWA
Correspondent
Totoku Electric Co., Ltd.
300 Oya , Ueda-Shi,
Nagano-Ken,  JP 386-0192
Correspondent Contact MIKIO HASEGAWA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/19/2003
Decision Date 02/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-