
Retinalabs.Com
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PDT DOSECALCULATOR, MODEL 80000 is an FDA 510(k)-cleared medical device (K000418) manufactured by Retinalabs.Com. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2000. Regulation: 8.