
Grason-Stadler, Inc.
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GSI 2000 MIDDLE EAR ANALYZER is an FDA 510(k)-cleared medical device (K000097) manufactured by Grason-Stadler, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 2000. Regulation: 8.

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