
Philips Medical Systems
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PICOSAT II SPO2 PULSE OXIMETRY MODULE is an FDA 510(k)-cleared medical device (K030973) 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 22, 2003. Regulation: 8.