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 K001729
Device Name FOCUS
Applicant
INSTRUMENTARIUM CORP.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207
Applicant Contact DOUG WOODS
Correspondent
INSTRUMENTARIUM CORP.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207
Correspondent Contact DOUG WOODS
Regulation Number872.1800
Classification Product Code
EHD  
Date Received06/07/2000
Decision Date 07/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-