
BTL Industries, Inc.
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BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS is an FDA 510(k)-cleared medical device (K100310) manufactured by BTL Industries, 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 12, 2010. Regulation: 8.