
Shanghai 3f Electronics Co, Ltd.
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MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A is an FDA 510(k)-cleared medical device (K100394) manufactured by Shanghai 3f Electronics Co, Ltd.. 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 14, 2010. Regulation: 8.