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 K152863
Device Name Portable ECG Monitor
Applicant
CONTEC MEDICAL SYSTEMS CO., LTD
NO. 112 QINHUANG WEST STREET, ECONOMIC &
TECHNICAL DEVELOPMENT ZONE
qinhuangdao,  CN 066004
Applicant Contact xueyong li
Correspondent
MID-LINK CONSULTING CO., LTD
P.O. BOX 120-119
shanghai,  CN 200120
Correspondent Contact diana hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/30/2015
Decision Date 06/22/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-