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 Electrode, Pacemaker, Temporary
510(k) Number K241199
Device Name Rotatable Connector (5944RL)
Applicant
Shenzhen Launch Electrical Co., Ltd.
Bldg. F, Zhonggangxing Industrial Estate Zhangge Community
Guanian St., Longhua New District
Shenzhen,  CN 518110
Applicant Contact Christina Zheng
Correspondent
Shenzhen Launch Electrical Co., Ltd.
Bldg. F, Zhonggangxing Industrial Estate Zhangge Community
Guanian St., Longhua New District
Shenzhen,  CN 518110
Correspondent Contact Christina Zheng
Regulation Number870.3680
Classification Product Code
LDF  
Date Received04/30/2024
Decision Date 01/23/2025
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
-
-