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Bionet Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
4
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K231160Cardio Q50, Cardio Q70December 15, 2023
K231150Cardio P1November 9, 2023
K220535Cardio10November 15, 2022
K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) anOctober 11, 2022
K130322SPM-300November 15, 2013
K113306CARDIO 7July 16, 2012
K102767CARDIO XPJune 3, 2011
K090895EKG-PLUS II SOFTWAREAugust 26, 2009
K082008BIONET BM3PLUS PATIENT MONITORDecember 11, 2008
K043598FC 1400 FETAL MONITORDecember 16, 2005
K043597FC 700 FETAL MONITORDecember 16, 2005