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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 the device name listed in this FDA 510(k) record. The listed applicant is Bionet Co., Ltd.. It received FDA 510(k) clearance on 2022-11-15 under 510(k) 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. The listed applicant is Bionet Co., Ltd.. The 510(k) number is K220535.

When did Cardio10 receive FDA 510(k) clearance?

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

Who is the listed applicant for Cardio10?

The FDA 510(k) record lists Bionet Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardio10?

The FDA product code for Cardio10 is DPS.

Other records listing Bionet Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231160Cardio Q50, Cardio Q70K231150Cardio P1K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

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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