Device Recall Sonotrax

  • Model / Serial
    Product is uncoded.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 89 consumers nationwide.
  • Product Description
    Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate and is labeled as: Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Danatech Medical Systems Inc, 7275 Nw 68th St Ste 1, Miami FL 33166-3094
  • Source
    USFDA