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MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. vs Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.: FDAPulse comparison

MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.'s review days of 276 is 1.2x Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.'s 238 (95th percentile). MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. is dated 2026-10-05; Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc. 2026-10-23.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. compare to Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.?

FieldMyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK260005K260640
DeviceMyoVista wavECG (DG-200-B15-003)Kinetic Software Library
ApplicantHeartSciences, Inc.Monebo Technologies, Inc.
Specialty / panelCardiovascularCardiovascular
Product codeDPSDPS
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-01-022026-02-27
Decision date2026-10-052026-10-23
Review time (days)276238
Third-party reviewNoNo
Applicant locationSouthlake, TX, USAustin, TX, US
amount percentile95th76th
Predicate Speed & CAPA Advisory Opportunity Score61/10054/100
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Official records: MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. · Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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