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

Clearance record K113156

SONOSITE EDGE ULTRASOUND SYSTEM · Sonosite,Inc. · decided 2011-11-15 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Edge Mini-DockP15078-16FUJIFILM SONOSITE, INC.ITX IYN IYO00841517107598
SonoSite EdgeP28961-68RFUJIFILM SONOSITE, INC.ITX IYN IYO00841517105754
Edge Mini-DockP30376-01FUJIFILM SONOSITE, INC.ITX IYN IYO OIJ00841517108113
Edge Mini-DockP15078-43FUJIFILM SONOSITE, INC.ITX IYN IYO00841517110369
L38xi/10-5 MHz ArmoredP19626-20AFUJIFILM SONOSITE, INC.ITX IYN IYO00841517107628
BatteryP30415-01FUJIFILM SONOSITE, INC.ITX IYN IYO OIJ00841517106829
BatteryP15051-26FUJIFILM SONOSITE, INC.ITX IYN IYO00841517109585
Edge StandP15800-55FUJIFILM SONOSITE, INC.ITX IYN IYO00841517106447
Triple Transducer ConnectP16535-52RFUJIFILM SONOSITE, INC.ITX IYN IYO00841517110352