BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000

BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 is an FDA 510(k)-cleared medical device (K971437) manufactured by Murray Electronics. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1997. Regulation: 8.