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 K241197
Device Name DeepRhythmAI
Applicant
Medicalgorithmics S.A.
Aleje Jerozolimskie 81
Warsaw,  PL 02-001
Applicant Contact Joanna Dabala
Correspondent
Medicalgorithmics S.A.
Aleje Jerozolimskie 81
Warsaw,  PL 02-001
Correspondent Contact Joanna Dabala
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DPS   QYX  
Date Received04/30/2024
Decision Date 12/04/2024
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
-
-