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Cambridge Heart CH 2000 Cardiac Diagnostic System

by Cambridge Heart, Inc.

510(k) K981697

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 NumberK981697 Date14 Oct 1998ClearedStatusActive

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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
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.

The Cambridge Heart CH 2000 Cardiac Diagnostic System is a device that records electrocardiograms (ECG) and vector cardiograms. It processes cardiac signals to detect alternans and provides output to healthcare providers for diagnostic or prognostic evaluation.

The system is used at rest or during stress testing and is operated by or under the direction of a physician in clinical settings. It received FDA 510(k) clearance under K981697 and is classified under product code DPS with advisory committee review in cardiovascular (CV) devices.

Other devices from Cambridge Heart, Inc.

See all devices from Cambridge Heart, Inc. →

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 Cambridge Heart CH 2000 Cardiac Diagnostic System used for?

    The Cambridge Heart CH 2000 Cardiac Diagnostic System records electrocardiograms (ECG) and vector cardiograms, processes cardiac signals to detect alternans, and provides output to healthcare providers for diagnostic or prognostic evaluation. It is used at rest or during stress testing under physician direction in clinical settings.

  • How is the Cambridge Heart CH 2000 Cardiac Diagnostic System supplied and operated?

    The system is operated by or under the direction of a physician in clinical settings. It is used at rest or during stress testing to record and process cardiac signals for alternans detection, providing diagnostic or prognostic output to healthcare providers.

  • What regulatory pathway was used for the Cambridge Heart CH 2000 Cardiac Diagnostic System?

    The Cambridge Heart CH 2000 Cardiac Diagnostic System received FDA 510(k) clearance under K981697, with a decision of substantially equivalent (SESE) on October 14, 1998, following a traditional clearance type and advisory committee review in cardiovascular devices.