Device Recall Isotechnology, Isobalance System

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 07-001 through 07-030.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.
  • 제품 설명
    Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Acacia Engineered Products LLC, 1108 Harpeth Industrial Ct, Franklin TN 37064-2224
  • 제조사 모회사 (2017)
  • Source
    USFDA