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, Cutaneous
510(k) Number K150971
Device Name Zekang Self-adhesive Electrode
Applicant
Jiangsu Zekang Medical Technology Co., Ltd.
Bldg. 22, Wuxi Zhongguancun Software Park
Wuxi,  CN 214135
Applicant Contact Doris Dong
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 1706, #128 Songle Rd., Songjiang Area
Shanghai,  CN 201600
Correspondent Contact Doris Dong
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/13/2015
Decision Date 08/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-