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

Clearance record K180912

TE7/TE5 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · decided 2018-07-30 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
L14-6Ns Ultrasonic Probe(FDA)120-018844-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415925871
L12-3RCs Ultrasonic Transducer(FDA)120-012542-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415903053
Table StandTCN17-GG001-F-013Shenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN06944904092652
SC6-1s Ultrasonic Probe(FDA)120-013162-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415911706
C4-1s Ultrasonic Probe(FDA)120-007621-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415903060
L12-3RCs Ultrasonic Probe(FDA)120-018861-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415925932
M9 Li-ion battery FRU(FDA)115-023072-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.IYN06944904089621
L7-3s Ultrasonic Transducer(FDA)120-022047-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415978907
L14-6s Ultrasonic Transducer(FDA)120-022051-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415978891
L9-3s Ultrasonic Probe(FDA)120-004780-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06944904095479
L11-3VNs Ultrasonic Probe(FDA)120-007609-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06944904099613
L20-5s Ultrasonic Probe Konica(FDA)120-004754-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06944904092867
L20-5s Ultrasonic Probe(FDA)120-018857-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.ITX06936415925949