
Advantage Medical Systems, Inc.
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MODIFICATION FETAL MONITOR MODEL FM-2 is an FDA 510(k)-cleared medical device (K852518) manufactured by Advantage Medical Systems, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 4, 1985. Regulation: 8.

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