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FDA 510(k)

MyoVista wavECG (DG-200-B15-003)

K-Number: K260005 · 2026-10-05

ApplicantHeartSciences, Inc.
Decision Date2026-10-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MyoVista wavECG (DG-200-B15-003) is the device name listed in this FDA 510(k) record. The listed applicant is HeartSciences, Inc.. It received FDA 510(k) clearance on 2026-10-05 under 510(k) number K260005. 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 MyoVista wavECG (DG-200-B15-003)?

MyoVista wavECG (DG-200-B15-003) is a medical device that received FDA 510(k) clearance on 2026-10-05. The listed applicant is HeartSciences, Inc.. The 510(k) number is K260005.

When did MyoVista wavECG (DG-200-B15-003) receive FDA 510(k) clearance?

MyoVista wavECG (DG-200-B15-003) received FDA 510(k) clearance on 2026-10-05, under 510(k) number K260005.

Who is the listed applicant for MyoVista wavECG (DG-200-B15-003)?

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

What is the FDA product code for MyoVista wavECG (DG-200-B15-003)?

The FDA product code for MyoVista wavECG (DG-200-B15-003) is DPS.

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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.

K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc.K254255S-Patch CardioAIWellysis Corp.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)Withings

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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