AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.

AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. is an FDA 510(k)-cleared medical device (K880581) manufactured by Synectics-Dantec. 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 August 10, 1988. Regulation: 8.