Otsuka Digital Feedback Device-RW

Otsuka Digital Feedback Device-RW is an FDA 510(k)-cleared medical device (K223463) manufactured by Otsuka America Pharmaceutical, 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 August 10, 2023. Regulation: 8.