SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR

SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR is an FDA 510(k)-cleared medical device (K983355) manufactured by Sabratek Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 1999. Regulation: 8.