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 software for over-the-counter use
510(k) Number K201525
Device Name ECG App
Applicant
Apple Inc.
One Apple Park Way
Cupertino,  CA  94015
Applicant Contact Luke Olson
Correspondent
Apple Inc.
One Apple Park Way
Cupertino,  CA  94015
Correspondent Contact Luke Olson
Regulation Number870.2345
Classification Product Code
QDA  
Date Received06/08/2020
Decision Date 10/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-