Edan Instruments, Inc.

  • Manufacturer Address
    Edan Instruments, Inc., 7/F, Yuehai Office Bldg., 1128 Nanyou Road, Nanshan, Shenzhen Guangdong China
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • 1 Event

One device in the database

  • Model / Serial
    Lot Numbers: P09100310 P09100406 P09100428
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Dominica, Ecuador, Colombia, Honduras, Peru, Mexico, El Salvador, Guatemala, Venezuela, Uruguay, Chile, Panama, Nicaragua, Ecuador, Australia, Philippines, Malaysia, Indonesia, Chinese Taipei, & Spain
  • Product Description
    ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph || ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.