SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS

SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS is an FDA 510(k)-cleared medical device (K974698) manufactured by Siemens Medical Solutions USA, 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 7, 1998. Regulation: 8.