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 K232699
Device Name Low Ejection Fraction AI-ECG Algorithm
Applicant
Anumana, Inc.
One Main Street, Suite 400
East Arcade, 4th Floor
Cambridge,  MA  02142
Applicant Contact Suzanne Goodman
Correspondent
RQM+
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Alexia Haralambous
Regulation Number870.2380
Classification Product Code
QYE  
Date Received09/05/2023
Decision Date 09/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-