
Schaerer Mayfield USA, Inc.
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MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 is an FDA 510(k)-cleared medical device (K041897) manufactured by Schaerer Mayfield USA, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2005. Regulation: 8.