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 Computer, Diagnostic, Programmable
510(k) Number K212662
Device Name AliveCor QT Service
Applicant
AliveCor, Inc.
189 N. Bernardo Ave.
Suite 100
Mountain View,  CA  94043
Applicant Contact Susan Noriega
Correspondent
Mdqr, LLC
189 N. Bernardo Ave.
Suite 100
Mountain View,  CA  94043
Correspondent Contact Prabhu Raghavan
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received08/23/2021
Decision Date 04/26/2022
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
-
-