Device Recall Spacelabs Medical Ultraview SL Command Module, Model 91496

  • 모델명 / 제조번호(시리얼번호)
    Serial number: 1496-029792
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    One device distributed in Troy, MI.
  • 제품 설명
    Spacelabs Medical Ultraview SL Command Module, Model 91496. || The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
  • Source
    USFDA