
Fink Engineering Pty, Ltd.
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SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES is an FDA 510(k)-cleared medical device (K031649) manufactured by Fink Engineering Pty, Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2003. Regulation: 8.