FDA 510(k) Search

K Number

K241179

Device Name

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

Manufacturer

VivaQuant, Inc.

Date Cleared

2025-07-11

Product Code

MLO

Regulation Number

870.2800

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

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Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

null

Therapeutic

null

Diagnostic

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SaMD (Software as a Medical Device)

null

IVD (In Vitro Diagnostic)

null

PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Summary

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