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 oximeter, tissue saturation
510(k) Number K093923
Device Name CEROX MODEL 3210
Applicant
OR-NIM MEDICAL LTD.
1 YODFAT ST
LOD,  IL 71291
Applicant Contact MICHAL BALBERG, PHD
Correspondent
OR-NIM MEDICAL LTD.
1 YODFAT ST
LOD,  IL 71291
Correspondent Contact MICHAL BALBERG, PHD
Regulation Number870.2700
Classification Product Code
MUD  
Date Received12/22/2009
Decision Date 01/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-