PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)

PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) is an FDA 510(k)-cleared medical device (K133263) 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 February 6, 2014. Regulation: 8.