OPTI Medical Systems Inc. / Medical Device Software / EMC / Bionostics Inc. / Level 3 / Regulatory Affairs OPTI Medical Systems Inc. / /
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pence / / /
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FDA Phase / /
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Laboratory Use Part / / /
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IndustryTerm
communications communication / mm base gas bottles / end-product / calibration gas bottle / electronic hardware / gas valve module / manufacturing costs / Metal and plastic frame / Metal frame / gas bottle housing base / aqueous quality control solution / analyzer with modified hardware / portable applications / treatment of certain renal and metabolic diseases / gas bottles / treatment of parathyroid disease / gas bottle / electronics / manufacturing / software architecture / treatment of carbohydrate metabolism disorders / updated electronics / internal site / software control / reflectance technology / /
5 10(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMVDA 1990 and 21 CER[removed]k) Number k131126 2. Applicant: