AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT

AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT is an FDA 510(k)-cleared medical device (K902261) 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 July 15, 1990. Regulation: 8.