AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)

AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) is an FDA 510(k)-cleared medical device (K883434) 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 September 13, 1988. Regulation: 8.