VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229

VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 is an FDA 510(k)-cleared medical device (K935701) manufactured by Starkey Laboratories, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 9, 1994. Regulation: 8.