STAT-SHELL DISPOSABLE SPO2 SENSOR

STAT-SHELL DISPOSABLE SPO2 SENSOR is an FDA 510(k)-cleared medical device (K992092) manufactured by Epic Medical Equipment Services, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 1999. Regulation: 8.