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

Clearance record K243765

LuMon(TM) System · Sentec AG · decided 2025-08-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
1ST120-100 LuMon™ Connector 2.0 1ST120-100SenTec AGBZQ QEBEIT11ST1201000
103583 LuMon™ Contact Gel Kit103583SenTec AGBZQ QEB07640121881053
1ST276-100 LuMon™ Belt Size 351ST276-100SenTec AGBZQ QEBEIT11ST2761000
1ST278-100 LuMon™ Belt Size 471ST278-100SenTec AGBZQ QEBEIT11ST2781000
1ST282-100 LuMon™ Belt Size 801ST282-100 SenTec AGBZQ QEBEIT11ST2821000
1ST273-100 LuMon™ Belt Size 221ST273-100SenTec AGBZQ QEBEIT11ST2731000
1ST275-100 LuMon™ Belt Size 301ST275-100SenTec AGBZQ QEBEIT11ST2751000
2ST200-100 LuMon™ Monitor 2ST200-100SenTec AGBZQ QEBEIT12ST2001000
1ST283-100 LuMon™ Belt Size 921ST283-100SenTec AGBZQ QEBEIT11ST2831000
1ST284-100 LuMon™ Belt Size 1041ST284-100SenTec AGBZQ QEBEIT11ST2841000
1ST277-100 LuMon™ Belt Size 401ST277-100SenTec AGBZQ QEBEIT11ST2771000
1ST285-100 LuMon™ Belt Size 1161ST285-100SenTec AGBZQ QEBEIT11ST2851000
1ST274-100 LuMon™ Belt Size 261ST274-100SenTec AGBZQ QEBEIT11ST2741000
1ST272-100 LuMon™ Belt Size 191ST272-100SenTec AGBZQ QEBEIT11ST2721000