• 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 K090807
Device Name REGIONAL OXIMETER SYSTEM, MODEL 7600
Original Applicant
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth,  MN  55441 -5443
Original Contact lori m roth
Regulation Number870.2700
Classification Product Code
MUD  
Date Received03/25/2009
Decision Date 06/30/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-