About This 510(k) Submission
K974775 is an FDA 510(k) clearance for the SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Airtronic Services, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on February 19, 1998, 59 days after receiving the submission on December 22, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.