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 Stethoscope, Electronic
510(k) Number K220766
Device Name eMurmur Heart AI
Applicant
CSD Labs GmbH
Nikolaiplatz 4
Graz,  AT 8020
Applicant Contact Andreas Reinisch
Correspondent
RQM+
2251 San Diego Ave, Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison Komiyama
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DQC  
Date Received03/16/2022
Decision Date 05/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-