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 K180773
Device Name Reusable and Self-Adhesive Electrodes
Applicant
Shaoxing Dongzhi Electrical Technology Co., Ltd.
Xinsha Village, Cao E St., Shangyu Area
Shaoxing,  CN 312352
Applicant Contact Haze XU
Correspondent
Shaoxing Dongzhi Electrical Technology Co., Ltd.
Xinsha Village, Cao E St., Shangyu Area
Shaoxing,  CN 312352
Correspondent Contact Haze XU
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/23/2018
Decision Date 05/22/2018
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
-
-