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 K912893
Device Name ORTHOPANTOMOGRAPH 100
Applicant
Instrumentarium Corp.
Teollisuuskatu 27
00510 Helsinki 51
Finland,  FI
Applicant Contact PEKKA MARTTINEN
Correspondent
Instrumentarium Corp.
Teollisuuskatu 27
00510 Helsinki 51
Finland,  FI
Correspondent Contact PEKKA MARTTINEN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/01/1991
Decision Date 11/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-