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 Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K243438
Device Name MEMO Patch M (MPT-E08R-UNC01)
Applicant
HUINNO Co., Ltd.
3f, 4f, 5f, 19, Apgujeong-Ro 79-Gil, Gangnam-Gu
Seoul,  KR 06011
Applicant Contact Kang Yongwan
Correspondent
Lighten Bridge, LLC
4408 Tortuga Ln
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number870.2920
Classification Product Code
DXH  
Date Received11/06/2024
Decision Date 12/05/2025
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
-
-