
Impact Instrumentation, Inc.
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UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR is an FDA 510(k)-cleared medical device (K103318) manufactured by Impact Instrumentation, 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 April 6, 2011. Regulation: 8.