1 device · 1 company · 2019

Product code MUD: Oximeter, Tissue Saturation

1 device under product code MUD, 2019, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.

Oximeter, Tissue Saturation. 21 CFR 870.2700, Class II. MAUDE held 744 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved from FDA public records.

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MUD · 1 device
DecisionDeviceCompanyPanelFDA
MIMOSA ImagerK190334 · 510(k)MIMOSA Diagnostics IncCardiovasculardatabase entry

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