
Somanetics Corp.
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ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 is an FDA 510(k)-cleared medical device (K001842) manufactured by Somanetics Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2000. Regulation: 8.