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 K180232
Device Name DAEHAN Disposable CUP Electrodes
Applicant
Daehan Medical Systems Co., Ltd.
250 Okgucheondong-Ro
Siheung-City,  KR 15084
Applicant Contact Da Roo Ha
Correspondent
Daehan Medical Systems Co., Ltd.
250 Okgucheondong-Ro
Siheung-City,  KR 15084
Correspondent Contact Da Roo Ha
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/29/2018
Decision Date 04/03/2019
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
-
-