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康泰医学(300869.SZ):医疗器械产品获得美国FDA批准函

Kangtai Medical (300869.SZ): Medical device products obtained approval letter from the US FDA

Gelonghui Finance ·  May 6 06:29

Gelonghui, May 6 | Kangtai Medical (300869.SZ) announced that recently, Kangtai Medical System (Qinhuangdao) Co., Ltd. received a Substantial Equivalence Letter (“FDA”) issued by the U.S. Food and Drug Administration (“FDA”). The company's products ColorDoppler Ultrasound Diagnostic System (CMS1700B, CMS1700C) and B-Ultrasound Diagnostic System B-ultrasound diagnostic equipment (CMS600P2PLUS) have passed FDA's 510 (K) substantive equivalent approval. The 510 (K) numbers are K232908 and K232895, respectively.

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