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 Electrocardiograph
510(k) Number K200036
Device Name AI-ECG Tracker
Applicant
Shenzhen Carewell Electronics Co., Ltd.
Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park
Songbai Road, Xili Street
Shenzhen,  CN 518108
Applicant Contact Chang Liu
Correspondent
FDA Regulatory and Quality Systems Consultant
31853 Cedar Road
Mayfield Heights,  OH  44124 -4445
Correspondent Contact Arthur Goddard
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DQK  
Date Received01/08/2020
Decision Date 03/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-