Device Recall Dermonosonic NonInvasive Subdermal Therapy System

  • 모델명 / 제조번호(시리얼번호)
    serial numbers: 8, 960, 1341, 1343, 1344, 1351 through 1354, 1359, 1363, 1365 through 1368, 1372,  1379, 1581, 1583, 1584, 1589 through 1593, 1598, 1599, 1756, 1757, 1760, 1771,  1784, 1786, 1792, 1793, 2001, 2005, 2007, 2012 through 2018, 2020 through 2025, 2028, 2029, 2031, 2032, 2036, 2037, 2038, 2041, 2043, 2044, 2047,  2175, 2176, 2177, 2180 through 2187, 2189 through 2195, 2197, 2198, 2348, 2355 through 2370, 2372, 2373, 2374, 2375, 2376, 2378, 2381, 2382,  2389, 2390, 2392, 2393, 2400 through 2433, 2435, 2436, 2442, 2443, 2453, 2475, 2560,  2562, 2563, 2564, 2565, 2566, 2568, 2569, 2572 through 2579, 2590, 2592, 2593, 2595, 2596, 2597, 2598, and 2599
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AZ, CA, CO, CT, FL, GA, ID, IL, IA, KS, LA, MA, MI, MN, NV, NJ, NM, NY, NC, OH, OK, OR, SC, SD, TN, TX, UT, VA & WI and to the Phillipines
  • 제품 설명
    Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA