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Bio Medical Technologies Co., Ltd.
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OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P is an FDA 510(k)-cleared medical device (K092549) manufactured by Bio Medical Technologies Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 2009. Regulation: 8.