• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name oximeter, tissue saturation
510(k) Number K100875
Device Name CEROX, MODEL 321OF
Original Applicant
1 yodfat st
lod,  IL 71291
Original Contact michal balberg
Regulation Number870.2700
Classification Product Code
Subsequent Product Code
Date Received03/30/2010
Decision Date 01/25/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No