
Heartsine Technologies, Inc.
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REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 is an FDA 510(k)-cleared medical device (K052465) manufactured by Heartsine Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 11, 2006. Regulation: 8.