
Pentax Medical
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PENTAX Medical EPK-3000 Video Imaging System is an FDA 510(k)-cleared medical device (K172156) manufactured by Pentax Medical. 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 4, 2018. Regulation: 8.

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