
Respironics Georgia, Inc.
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SMARTMONITOR 2, MODEL 4000 is an FDA 510(k)-cleared medical device (K011597) manufactured by Respironics Georgia, 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 January 10, 2002. Regulation: 8.