
Aspect Medical Systems, Inc.
Free shipping on orders over $99 · 30-day returns
BIS ENGINE is an FDA 510(k)-cleared medical device (K002837) manufactured by Aspect Medical 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 September 18, 2000. Regulation: 8.