
Axon Systems, Inc.
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SUNSPOTS PRE-GELLED SURFACE ELECTRODES is an FDA 510(k)-cleared medical device (K062198) manufactured by Axon Systems, 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 December 18, 2006. Regulation: 8.