Symphony DR and ELA Rhapsody DR

  • 모델명 / 제조번호(시리얼번호)
    Symphony DR 2250 serial numbers: 238WG020, 243WG055, 246WG094, 246WG109, 250WG029, 303WG027, 303WG038, 303WG074, 303WG078, 306WG073, 309WG262, 314WG057, 315WG188 and 320WG220.   Rhapsody DR 2510 Serial numbers: 318WJ010, 318WJ060 and 318WJ061
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
  • 제품 설명
    Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA