SPACELABS MEDICAL DISPOSABLE SP02 SENSOR

SPACELABS MEDICAL DISPOSABLE SP02 SENSOR is an FDA 510(k)-cleared medical device (K981655) manufactured by Spacelabs Medical, 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 2, 1999. Regulation: 8.