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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 the device name listed in this FDA 510(k) record. The listed applicant is Zbeats, Inc.. It received FDA 510(k) clearance on 2025-07-10 under 510(k) 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. The listed applicant is Zbeats, Inc.. The 510(k) number is K243252.

When did ZBPro Diagnostic receive FDA 510(k) clearance?

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

Who is the listed applicant for ZBPro Diagnostic?

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

What is the FDA product code for ZBPro Diagnostic?

The FDA product code for ZBPro Diagnostic is DPS.

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 CommercialK243305Masimo W1Masimo Corporation

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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