BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.

BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. is an FDA 510(k)-cleared medical device (K930105) manufactured by Helix Medical, 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 16, 1993. Regulation: 8.