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 K181310
Device Name HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
Applicant
CardioComm Solutions, Inc.
259 Yorkland Road, Suite 200
North York,  CA L0A 1J0
Applicant Contact Jill Turcotte
Correspondent
CardioComm Solutions, Inc.
259 Yorkland Road, Suite 200
North York,  CA L0A 1J0
Correspondent Contact Jill Turcotte
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/17/2018
Decision Date 02/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-