
Hewlett-Packard Co.
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SAECG CARDIOGRAPH MODEL M1754A is an FDA 510(k)-cleared medical device (K913997) manufactured by Hewlett-Packard Co.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 1992. Regulation: 8.