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 K230613
Device Name SKEEPER
Applicant
Smartsound Corporation
171, Yangjaecheon-ro, Gangnam-gu
Seoul,  KR 06302
Applicant Contact Jungho Lee
Correspondent
Smartsound Corporation
171, Yangjaecheon-ro, Gangnam-gu
Seoul,  KR 06302
Correspondent Contact Jungho Lee
Regulation Number870.1875
Classification Product Code
DQD  
Date Received03/06/2023
Decision Date 08/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-