MODEL 9101 RECORDER/ANALYZER SYSTEM

MODEL 9101 RECORDER/ANALYZER SYSTEM is an FDA 510(k)-cleared medical device (K901251) manufactured by Aequitron 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 May 21, 1990. Regulation: 8.