
Suiter Enterprises, Inc.
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SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) is an FDA 510(k)-cleared medical device (K042294) manufactured by Suiter Enterprises, 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 9, 2004. Regulation: 8.