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Ambulatory ECG Digital Monitor Model: TD-30

by Cardiotechnics, Inc.

510(k) K880615

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880615 Date13 May 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

An ambulatory ECG digital monitor is a device designed to record heart rhythm during daily activities. It is used to detect clinically significant rhythm disturbances and waveform abnormalities that may be missed on a standard electrocardiogram.

The device is supplied as a reusable system for temporary nontherapeutic ambulatory cardiac monitoring. It received FDA 510(k) clearance (K880615) on May 13, 1988, and is classified under regulation 870.2920 as a transmitter and receiver, electrocardiograph, telephone, with product code DXH and medical specialty cardiovascular.

Questions

AI-generated answers, 25 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 AMBULATORY ECG DIGITAL MONITOR MODEL TD-30 used for?

    It is used to record heart rhythm during daily activities to detect clinically significant rhythm disturbances and waveform abnormalities that may be missed on a standard electrocardiogram, supporting temporary nontherapeutic ambulatory cardiac monitoring.

  • How is the AMBULATORY ECG DIGITAL MONITOR MODEL TD-30 supplied and is it reusable?

    The device is supplied as a reusable system for temporary nontherapeutic ambulatory cardiac monitoring, meaning it can be used multiple times after appropriate cleaning and maintenance between uses.

  • What regulatory clearance does the AMBULATORY ECG DIGITAL MONITOR MODEL TD-30 have?

    It received FDA 510(k) clearance (K880615) on May 13, 1988, and is classified under regulation 870.2920 as a transmitter and receiver, electrocardiograph, telephone, with product code DXH.