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 Device, Medical Examination, Ac Powered
510(k) Number K945507
Device Name H 5100, H 5200, H 5300
Applicant
Rudolf Riester GmbH & Co. KG
Postfach 35
Bruckstrabe 31
D-72417 Jungingen,  DE
Applicant Contact KARLHEINZ RIESTER
Correspondent
Rudolf Riester GmbH & Co. KG
Postfach 35
Bruckstrabe 31
D-72417 Jungingen,  DE
Correspondent Contact KARLHEINZ RIESTER
Regulation Number880.6320
Classification Product Code
KZF  
Date Received11/09/1994
Decision Date 12/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-