
Pulse Biomedical, Inc.
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QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB is an FDA 510(k)-cleared medical device (K100813) manufactured by Pulse Biomedical, 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 July 22, 2010. Regulation: 8.