Device Recall System 98XT/98 IntraAortic Balloon Pump

  • 모델명 / 제조번호(시리얼번호)
    Product number 0998-00-0446-XX and 0998-00-0479-XX. SN# S8119767B8 S8119768B8 S8119769B8 S8119771B8 S8119773B8 S8119774B8 S8119775B8 S8119778B8 S8119780B8 S8119781B8 S8119782B8 S8119764B8 S8119766B8 S8119770B8 S8119772B8 S8119776B8 S8119779B8
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
  • 제품 설명
    System 98XT/98 Intra-Aortic Balloon Pump || This product was only distributed in India and Hong Kong/China.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • 제조사 모회사 (2017)
  • Source
    USFDA