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Tempusic Patient Monitor

by Remote Diagnostic Technologies Ltd. 2 variants

510(k) K082718

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082718↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK082718 Date10 Oct 2008ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DXH
FDA applicant
Remote Diagnostic Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Tempusic Patient Monitor is a transmitter and receiver device for electrocardiograph (ECG) monitoring, designed to transmit cardiac signals via telephone lines. It falls under the classification of transmitters and receivers for remote cardiac monitoring, enabling real-time or delayed ECG data transmission for clinical assessment.

This device is intended for use in clinical settings, including hospitals and outpatient facilities, where continuous or intermittent cardiac monitoring is required. Supplied as a reusable medical device, it operates in non-MRI environments and requires proper calibration and maintenance. Authorised under FDA 510(k) and MDD compliance, it adheres to regulatory standards for cardiovascular monitoring equipment, with specific reference codes and registration numbers listed for traceability.

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Questions

AI-generated answers, 18 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 clinical environments is the Tempusic Patient Monitor designed for, and how does it support cardiac monitoring needs there?

    The Tempusic Patient Monitor is specifically designed for clinical settings like hospitals and outpatient facilities where continuous or intermittent cardiac monitoring is required. It transmits electrocardiograph (ECG) signals via telephone lines, enabling real-time or delayed data transfer for clinical assessment. This makes it ideal for environments where remote monitoring of cardiac activity is necessary, such as intensive care units, cardiac wards, or outpatient clinics with limited on-site ECG capabilities.

  • Is the Tempusic Patient Monitor reusable or single-use, and what maintenance does it require?

    The Tempusic Patient Monitor is a reusable medical device, meaning it is intended for repeated use across multiple patients after proper cleaning, calibration, and maintenance. Since it operates in non-MRI environments, regular servicing and adherence to manufacturer guidelines are essential to ensure accurate ECG signal transmission and device reliability.

  • What regulatory pathways has the Tempusic Patient Monitor followed, and how does this affect its use?

    The Tempusic Patient Monitor has been authorized under both the FDA’s 510(k) pathway and the Medical Device Directive (MDD) in Europe. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device in the U.S. and compliance with EU safety and performance standards. Clinicians and buyers can rely on its adherence to these frameworks, ensuring it meets established benchmarks for cardiovascular monitoring equipment.

  • Does the Tempusic Patient Monitor come in multiple sizes or models, and how would I identify the correct one for my facility?

    The Tempusic Patient Monitor is listed under multiple FEI numbers (e.g., 3013689228, 3011265784, etc.) and registration numbers, which correspond to different configurations or variants of the device. While the core functionality remains consistent—transmitting ECG signals via telephone lines—these identifiers help track specific models or versions for traceability and compliance. Contacting the manufacturer, Remote Diagnostic Technologies Ltd., or referencing the device’s documentation would clarify which model aligns with your facility’s needs.

  • How should the Tempusic Patient Monitor be stored, and are there any special handling requirements?

    As a reusable device, the Tempusic Patient Monitor should be stored in a clean, dry environment protected from physical damage or environmental contaminants. Since it requires calibration and maintenance, storage areas should also be accessible for servicing. The manufacturer’s instructions should be followed for specific storage guidelines, including any protective cases or conditions to preserve functionality and ensure longevity.