
Revivant Corp.
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MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 is an FDA 510(k)-cleared medical device (K032852) manufactured by Revivant Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 2003. Regulation: 8.