SPACELABS MODEL 90201 HOLTER RECORDER

SPACELABS MODEL 90201 HOLTER RECORDER is an FDA 510(k)-cleared medical device (K844940) manufactured by Spacelabs, 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 February 13, 1985. Regulation: 8.