BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER

BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER is an FDA 510(k)-cleared medical device (K983619) manufactured by Barchens Co.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 1998. Regulation: 8.