Cardio P1— 510(k) K231150

Name: FDA 510(k) clearance K231150
Creator: U.S. Food and Drug Administration
Published: 2023-11-09

Substantially Equivalent

Bionet Co., Ltd.

FDA 510(k) clearance K231150 for Cardio P1, Substantially Equivalent on 2023-11-09. Applicant: Bionet Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bionet Co., Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2023-04-21
Decision date: 2023-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

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K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

More clearances from Bionet Co., Ltd.

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K231160 — Cardio Q50, Cardio Q702023-12-15
K220535 — Cardio102022-11-15
K220169 — SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)2022-10-11
K130322 — SPM-3002013-11-15
K113306 — CARDIO 72012-07-16

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.