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

Clearance record K220012

BresoDX1 · Bresotec, Inc. · decided 2022-12-21 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
BresoDX1 Accessory KitBTSM1-UFBTSBresoTec IncMNR00990008600060
BresoDX1 Main KitBTSM1US-DCUURUBresoTec IncMNR00990008600053
BresoDX1BresoHubBTSM1US-DCUBresoTec IncMNR00990008600015
BresoDX1 BresoSensor FrameBTSM1-UFBresoTec IncMNR00990008600039
BresoDX1 BresoSensorBTSM1US-URUBresoTec IncMNR00990008600022
BresoDX1 Master KitBTSM1USBresoTec IncMNR00990008600077
BresoDX1 Tape StripsBTSM1-BTSBresoTec IncMNR00990008600046