• 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
510(k) Number K061112
Device Name CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
Original Applicant
CONMED CORPORATION
525 french road
utica,  NY  13502
Original Contact ira duesler
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/21/2006
Decision Date 05/22/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-