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Pwv Medical Pty, Lt.
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SPHYGMOCOR MX MODEL SCOR-MX is an FDA 510(k)-cleared medical device (K002742) manufactured by Pwv Medical Pty, Lt.. 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, 2001. Regulation: 8.