
Stihler Electronic GmbH
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PRISMATHERM II, ASTOLINE is an FDA 510(k)-cleared medical device (K991159) manufactured by Stihler Electronic GmbH. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 1999. Regulation: 8.