AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS

AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS is an FDA 510(k)-cleared medical device (K042843) manufactured by Ambu, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 2004. Regulation: 8.