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FDA 510(k)

Kinetic Software Library

K-Number: K260640 · 2026-10-23

ApplicantMonebo Technologies, Inc.
Decision Date2026-10-23
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Kinetic Software Library is the device name listed in this FDA 510(k) record. The listed applicant is Monebo Technologies, Inc.. It received FDA 510(k) clearance on 2026-10-23 under 510(k) number K260640. 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 Kinetic Software Library?

Kinetic Software Library is a medical device that received FDA 510(k) clearance on 2026-10-23. The listed applicant is Monebo Technologies, Inc.. The 510(k) number is K260640.

When did Kinetic Software Library receive FDA 510(k) clearance?

Kinetic Software Library received FDA 510(k) clearance on 2026-10-23, under 510(k) number K260640.

Who is the listed applicant for Kinetic Software Library?

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

What is the FDA product code for Kinetic Software Library?

The FDA product code for Kinetic Software Library is DPS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Monebo Technologies, Inc. as applicant

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.

K063044CARDIOBELT ELECTRODE BELTK062282MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0K043380MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1

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.

K260005MyoVista wavECG (DG-200-B15-003)HeartSciences, Inc.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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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