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 Electrocardiograph
510(k) Number K170995
Device Name Electrocardiograph
Applicant
Edan Instruments, Inc.
#15 Jinhui Rd., Jinsha Community, Kengzi Sub-District
Shenzhen,  CN 518122
Applicant Contact Alice Yang
Correspondent
Edan Medical
1200 Crossman Ave., Suite 200
Sunnyvale,  CA  94086
Correspondent Contact Doug Worth
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/03/2017
Decision Date 06/02/2017
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
-
-