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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K123646

EMORY CARDIAC TOOLBOX 4.0 · Syntermed, Inc. · decided 2013-02-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Emory Cardiac Toolbox4.27720.29473SYNTERMED INCORPORATEDKPSB133ECTB422102190
Emory Cardiac Toolbox4.28706.22036SYNTERMED INCORPORATEDKPSB133ECTB42231102
Emory Cardiac Toolbox4.27720.29473SYNTERMED INCORPORATEDKPSB133ECTB422112080
Emory Cardiac Toolbox4.2.7559.13747SYNTERMED INCORPORATEDKPSB133ECTB422009110
Emory Cardiac Toolbox4.0.5121.18001SYNTERMED INCORPORATEDKPSB133ECTB40
Emory Cardiac Toolbox4.2.7003.28586SYNTERMED INCORPORATEDKPSB133ECTB400
Emory Cardiac Toolbox4.2.8339.22556SYNTERMED INCORPORATEDKPSB133ECTB42221031