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Best Medical International, Inc.
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BEST MODEL # 81-01 SERIES IR-192 SOURCES is an FDA 510(k)-cleared medical device (K042786) manufactured by Best Medical International, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2004. Regulation: 8.