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 Outpatient Cardiac Telemetry
510(k) Number K240653
Device Name SmartCardia 7L Platform (MCT)
Applicant
Smartcardia SA
Epfl Innovation Park Bldg. C
Lausanne,  CH 1015
Applicant Contact Srinivasan Murali
Correspondent
Steurer Consulting Group, LLC
800 Blue Quail Rd.
Keller,  TX  76248
Correspondent Contact Robert Steurer
Regulation Number870.1025
Classification Product Code
QYX  
Subsequent Product Codes
DRG   DSI  
Date Received03/07/2024
Decision Date 10/31/2024
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
-
-