HEMOBAND, MODELS HB-NS AND HB-NSXL

HEMOBAND, MODELS HB-NS AND HB-NSXL is an FDA 510(k)-cleared medical device (K081740) manufactured by Innovations For Access, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 2009. Regulation: 8.