Devices

Device Recall Maximo Concepts

  • 모델명 / 제조번호(시리얼번호)
    Item Codes: MAX91721, MAX91721CL, MAX91721B, MAX91721-6, MAX91721CL-16, MAX91721CL-FR, MAC91721CL-PDQ and MAX91721B-DW. The device does not contain any serial or control/lot numbers.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide to retail distribution centers in CA, CO, IL, KS, MA, MO, NE, NJ, NY, PA, VA and WI.
  • 제품 설명
    Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
  • Manufacturer
    Sakar International, Inc.
  • 1 Event

제조사

Sakar International, Inc.
  • 제조사 주소
    Sakar International, Inc., 195 Carter Drive, Edison NJ 08817-2068
  • 제조사 모회사 (2017)
    Sakar International Inc.
  • Source
    USFDA