• 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 transmitters and receivers, physiological signal, radiofrequency
510(k) Number K130971
Device Name OPTUM TELEHEALTH APPLICATION
Applicant
OPTUMHEALTH CARE SOLUTIONS, INC.
4 INNOVATION DR
dundas, on,  CA l9h 7p3
Applicant Contact roshana ahmed, ma, rac
Correspondent
OPTUMHEALTH CARE SOLUTIONS, INC.
4 INNOVATION DR
dundas, on,  CA l9h 7p3
Correspondent Contact roshana ahmed, ma, rac
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DQA   DXN  
Date Received04/08/2013
Decision Date 10/23/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-