• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K122712
Model ECG-8080, IE 3S, IE 6S, IE 12 AND IE12P
Device Name DIGITAL ELECTROCARDIOGRAPH
Original Applicant
SHENZHEN BIOCARE ELECTRONICS CO., LTD
p.o. box 237-023
shanghai,  CH 200237
Original Contact diana hong
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/04/2012
Decision Date 10/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-