• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name oximeter
510(k) Number K051107
Device Name ONYX II FINGER PULSE OXIMETER, MODEL 9550
Original Applicant
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth,  MN  55441 5443
Original Contact lori m roth
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/02/2005
Decision Date 06/01/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-