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 Reduced Ejection Fraction Machine Learning-Based Notification Software
510(k) Number K250649
Device Name Bunkerhill ECG-EF
Applicant
Bunkerhill Health
436 Bryant St.
San Francisco,  CA  94107
Applicant Contact Nishith Khandwala
Correspondent
Hogan Lovells Llp
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact John Smith
Classification Product Code
QYE  
Date Received03/04/2025
Decision Date 09/19/2025
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
-
-