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Smiths Medical Pm, Inc.
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BCI WW1030 PULSE OXIMETER is an FDA 510(k)-cleared medical device (K083557) 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 April 30, 2009. Regulation: 8.