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Smiths Medical Pm, Inc.
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BCI AUTOCON 3304 DIGITAL PULSE OXIMETER is an FDA 510(k)-cleared medical device (K070732) manufactured by Smiths Medical Pm, 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 July 8, 2007. Regulation: 8.