SPACELABS ICR ARRHYTHMIA MASTER I HOLTER

SPACELABS ICR ARRHYTHMIA MASTER I HOLTER is an FDA 510(k)-cleared medical device (K842640) 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 October 3, 1984. Regulation: 8.