
Philips Medical Systems
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THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT is an FDA 510(k)-cleared medical device (K041674) manufactured by Philips Medical Systems. 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 18, 2004. Regulation: 8.