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Cardiocap Tm CT-104 Monitor

by Datex Division Instrumentarium Corp.

510(k) K897080

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 NumberK897080 Date6 Mar 1990ClearedStatusActive

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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) as defined in the device specifications. It is a Class II cardiac monitor manufactured by Datex Division Instrumentarium Corp.

The device received FDA 510(k) clearance under K-number K897080 on March 6, 1990, and is substantially equivalent to a predicate device. It is used in cardiovascular settings and is supplied as a reusable monitoring system for cardiac activity, including rate and rhythm assessment.

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Questions

AI-generated answers, 1 Oct 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 CARDIOCAP(TM) CT-104 MONITOR used for?

    The CARDIOCAP(TM) CT-104 MONITOR is used in cardiovascular settings to monitor cardiac activity, including rate and rhythm assessment, as a cardiac monitor with cardiotachometer and rate alarm functions.

  • Is the CARDIOCAP(TM) CT-104 MONITOR reusable or single-use?

    The CARDIOCAP(TM) CT-104 MONITOR is supplied as a reusable monitoring system, meaning it is designed for multiple uses after appropriate cleaning and maintenance, not for single-use disposal.

  • What regulatory clearance does the CARDIOCAP(TM) CT-104 MONITOR have?

    The device received FDA 510(k) clearance under K-number K897080 on March 6, 1990, and is substantially equivalent to a predicate device, which means it meets the regulatory requirements for market entry through the traditional 510(k) pathway.