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

Clearance record K153408

HM70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · decided 2015-12-21 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Transducer CF4-9USP-CF49N2A/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167739348
VIDEO OUTUSO-EH7CS10/USSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167732813
Transducer LA3-16ADUSP-L03GN4A/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167749866
Transducer VN4-8USP-VN48N0A/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167739751
Transducer P3-8USP-PZ38NAA/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167740733
Transducer LS6-15USP-L06FN2A/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167752545
H70C 3P CARTUSO-CH7CN30/BRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167749088
CA1-7ADUSP-C017NSC/WRSAMSUNG MEDISON CO., LTD.ITX08809702985538
Transducer EVN4-9USP-GN49N0A/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167740221
Transducer C2-6ICUSP-CZ26NSB/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167739126
Transducer L7-16USP-LZ7GNS0/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167738839
Transducer PE2-4USP-PZ24NAA/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167740719
ACCESSORY SETUSO-YH7ANN0/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167750664
HM70A EXTENDED BATTERYUSO-AH7ALN0/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167752170
H70C 3P CARTUSO-CH7CN30/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167745424
H70C CARTUSO-CH7CN00/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167742416
HM70A Diagnostic Ultrasound SystemUSS-HM7AF1K/USSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167758073
VIDEO OUTUSO-EH7CS10/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167732769
Transducer C2-6USP-CZ26NS1/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167738778
ECG IECUSO-UH7EI00/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167742393
Transducer P3-8USP-PZ38NA0/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167738877
Transducer CV1-8ADUSP-V018NSA/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167752910
Transducer L7-16USP-LZ7GNSA/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167739102
H70C CARTUSO-CH7CN00/BRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167749422
Transducer CA1-7ADUSP-C017NSB/WRSAMSUNG MEDISON CO., LTD.ITX IYN IYO08806167758882