MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR

MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR is an FDA 510(k)-cleared medical device (K052554) manufactured by Versamed Medical Systems, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 2005. Regulation: 8.