UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF

UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF is an FDA 510(k)-cleared medical device (K894826) manufactured by Bentley Laboratories, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 1990. Regulation: 8.