Devices

Device Recall Isotechnology, Isobalance System

  • Modèle / numéro de série
    Serial numbers: 07-001 through 07-030.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
  • Description du dispositif
    Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
  • Manufacturer
    Acacia Engineered Products LLC
  • 1 Event

Fabricant

Acacia Engineered Products LLC
  • Adresse du fabricant
    Acacia Engineered Products LLC, 1108 Harpeth Industrial Ct, Franklin TN 37064-2224
  • Société-mère du fabricant (2017)
    Acacia Engineered Products
  • Source
    USFDA