• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K112803
Device Name PATIENT MONITOR
Original Applicant
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
p.o. box 237-023
shanghai,  CN 200237
Original Contact diana hong
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/27/2011
Decision Date 10/24/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-