• 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, electrocardiograph, telephone
510(k) Number K171816
Device Name Kardia Band System
AliveCor, Inc
444 Castro Street, Suite 600
mountain view,  CA  94041
Applicant Contact prabhu raghavan
Experien Group, LLC
224 Airport Parkway, Suite 250
san jose,  CA  95110
Correspondent Contact anna libman
Regulation Number870.2920
Classification Product Code
Subsequent Product Code
Date Received06/19/2017
Decision Date 11/16/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No