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FDA 510(k)

Cardio10

K-Number: K220535 · 2022-11-15

ApplicantBionet Co., Ltd.
Decision Date2022-11-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardio10 is a medical device manufactured by Bionet Co., Ltd.. It received FDA 510(k) clearance on 2022-11-15 under approval number K220535. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardio10?

Cardio10 is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by Bionet Co., Ltd.. The 510(k) number is K220535.

When was Cardio10 approved by the FDA?

Cardio10 received FDA 510(k) clearance on 2022-11-15, under approval number K220535.

What company makes Cardio10?

Cardio10 is manufactured by Bionet Co., Ltd..

What is the FDA product code for Cardio10?

The FDA product code for Cardio10 is DPS.

Other Devices by Bionet Co., Ltd.

K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) K231160Cardio Q50, Cardio Q70 K231150Cardio P1

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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