
Pulsion Medical Systems, Inc.
Free shipping on orders over $99 · 30-day returns
PULSIOFLEX is an FDA 510(k)-cleared medical device (K112448) manufactured by Pulsion Medical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 2011. Regulation: 8.