PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)

PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) is an FDA 510(k)-cleared medical device (K131009) manufactured by Proteus Digital Health, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 6, 2013. Regulation: 8.