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Impact Instrumentation, Inc.
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IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 is an FDA 510(k)-cleared medical device (K022062) 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 May 5, 2003. Regulation: 8.