
Pentax of America, Inc.
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PENTAX Medical Video Duedenoscope ED34-i10T2 is an FDA 510(k)-cleared medical device (K210710) manufactured by Pentax of America, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 8, 2021. Regulation: 8.