Device Recall ThermiSense model 5700A5

  • 모델명 / 제조번호(시리얼번호)
    Lot 110810
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, CO, DE, ID, IN, KY, MD, MO, and OH,
  • 제품 설명
    ThermiSense model 5700-A5 || The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA