
Diversatek Healthcare
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Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is an FDA 510(k)-cleared medical device (K190208) manufactured by Diversatek Healthcare. 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 October 2, 2019. Regulation: 8.