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R.Test Evolution

by Novacor Div.

510(k) K993788

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993788 Date4 Aug 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MLO
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The R.Test Evolution is an ambulatory electrocardiograph device equipped with an analysis algorithm. It is designed to detect and store pathologic cardiac events, including both symptomatic and asymptomatic episodes, while monitoring the patient's continuous heart rate.

This device is capable of up to 32 days of ambulatory monitoring and is intended for use as an automatic ECG arrhythmia detection system. It has received FDA 510(k) clearance under regulation number 870.2800.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the R.Test Evolution?

    The R.Test Evolution is an ambulatory electrocardiograph device designed to monitor a patient's continuous heart rate. It utilizes an integrated analysis algorithm to detect and store both symptomatic and asymptomatic pathologic cardiac events.

  • How long can the R.Test Evolution monitor a patient?

    This device is capable of providing up to 32 days of continuous ambulatory monitoring, allowing for an extended observation period to capture cardiac arrhythmia episodes.

  • What is the regulatory status of this device?

    The R.Test Evolution has received FDA 510(k) clearance under regulation number 870.2800. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.