BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER

BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER is an FDA 510(k)-cleared medical device (K962991) manufactured by Polymedica Industries, Inc.. 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 September 11, 1996. Regulation: 8.