Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K191406
Device Name KardiaMobile, KardiaStation
Applicant
AliveCor, Inc.
444 Castro St.
Suite 600
Mountain View,  CA  94041
Applicant Contact Saket Bhatt
Correspondent
AliveCor, Inc.
444 Castro St.
Suite 600
Mountain View,  CA  94041
Correspondent Contact Saket Bhatt
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Codes
DPS   QDA  
Date Received05/28/2019
Decision Date 01/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-