SPS 550-IPS (INTEGRATED PATIENT STATION)

SPS 550-IPS (INTEGRATED PATIENT STATION) is an FDA 510(k)-cleared medical device (K901038) manufactured by Baxter Healthcare Corp. 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 18, 1990. Regulation: 8.