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, Mammographic
510(k) Number K934478
Device Name ALPHA STEREO
Applicant
Instrumentarium Corp.
P.O. Box 20 (Nahkelantie 160)
Fin-04301
Tuusula, Finland,  FI
Applicant Contact RISTO MYNTTINEN
Correspondent
Instrumentarium Corp.
P.O. Box 20 (Nahkelantie 160)
Fin-04301
Tuusula, Finland,  FI
Correspondent Contact RISTO MYNTTINEN
Regulation Number892.1710
Classification Product Code
IZH  
Date Received09/14/1993
Decision Date 01/31/1995
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
-
-