Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZBPro Diagnostic

K-Number: K243252 · 2025-07-10

ApplicantZbeats, Inc.
Decision Date2025-07-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZBPro Diagnostic is a medical device manufactured by Zbeats, Inc.. It received FDA 510(k) clearance on 2025-07-10 under approval number K243252. 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 ZBPro Diagnostic?

ZBPro Diagnostic is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by Zbeats, Inc.. The 510(k) number is K243252.

When was ZBPro Diagnostic approved by the FDA?

ZBPro Diagnostic received FDA 510(k) clearance on 2025-07-10, under approval number K243252.

What company makes ZBPro Diagnostic?

ZBPro Diagnostic is manufactured by Zbeats, Inc..

What is the FDA product code for ZBPro Diagnostic?

The FDA product code for ZBPro Diagnostic is DPS.

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.

↑