Device Recall Ultrasound Video Gastroscope, Model EG3670URK

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411,  H110497, G110360, G110363, G110364, G110371, G110366, G110368,  G110372, H110434, H110447, G110380, H110455, G110298, H110445,  H110449, H110461, G110292, G110346, G110365, H110494, H110495,  H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467,  H110471, H110412, G110289, G110303, G110294, H110420, G110299,  G110300, H110448, H110452, G110386, G110331, H110451, H110493,  G110313, G110314, H110464, H110496, H110433, G110373, G110375,  G110317, H110431, H110417, G110291, G110302, G110369, G110378,  G110335, G110387, G110390, G110392, G110395, G110311, G110327,  G110332, G110382, G110355, G110357, G110287, G110320, H110435,  H110481, H110485, H110486, G110354, G110316, G110318, G110362,  G110393, H110498, H110456, H110457, H110459, G110337, G110356,  H110421, H110429, G110290, G110352, H110470, H110478, G110383,  G110384, G110361.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Ultrasound Video Gastroscope, Model EG-3670URK, || The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • 제조사 모회사 (2017)
  • Source
    USFDA