MODEL MR-30 HOLTER RECORDER

MODEL MR-30 HOLTER RECORDER is an FDA 510(k)-cleared medical device (K860181) manufactured by Oxford Medilog, 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 25, 1986. Regulation: 8.