
Burditt & Calkins-Siemens-Elema
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PULSE GENERATOR MODEL 688 is an FDA 510(k)-cleared medical device (K833519) manufactured by Burditt & Calkins-Siemens-Elema. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 29, 1984. Regulation: 8.

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