Intelligent Hearing Systems
SMARTEP-ASSR, MODEL M811007
SKU K031051UPC GWJ
In Stock
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IIFDA 510(k) Cleared (K031051)
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Intelligent Hearing Systems
Free shipping on orders over $99 · 30-day returns
SMARTEP-ASSR, MODEL M811007 is an FDA 510(k)-cleared medical device (K031051) manufactured by Intelligent Hearing Systems. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2004. Regulation: 8.
