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 unit, x-ray, extraoral with timer
510(k) Number K060292
Device Name KODAK MODELS 2100 AND 2200
Applicant
KODAK-TROPHY
4 RUE FERDINAND PELLOUTIER
CROISSY-BEAUBOURG
MARNE LA VALLEE CEDEX 2,  FR 77 437
Applicant Contact MARIE-PIERRE LABAT-CAMY
Correspondent
KODAK-TROPHY
4 RUE FERDINAND PELLOUTIER
CROISSY-BEAUBOURG
MARNE LA VALLEE CEDEX 2,  FR 77 437
Correspondent Contact MARIE-PIERRE LABAT-CAMY
Regulation Number872.1800
Classification Product Code
EHD  
Date Received02/06/2006
Decision Date 03/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-