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Monitor, Electrographic

by Medac, Inc.

510(k) K874319

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 NumberK874319 Date7 Mar 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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
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.

A Monitor, Electrographic is a Class II cardiac monitor that includes cardiotachometer and rate alarm functions. It is used in cardiovascular applications.

This device was cleared via the FDA 510(k) pathway under K874319 on March 7, 1988. It is manufactured by Medac, Inc. and distributed in the United States.

Other devices from Medac, Inc.

See all devices from Medac, 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 MONITOR, ELECTROGRAPHIC used for?

    The MONITOR, ELECTROGRAPHIC is a Class II cardiac monitor used in cardiovascular applications, featuring cardiotachometer and rate alarm functions to monitor heart activity and detect abnormal rates.

  • How was the MONITOR, ELECTROGRAPHIC cleared for market?

    The device was cleared via the FDA 510(k) pathway under submission K874319 on March 7, 1988, as substantially equivalent to a predicate device, following a traditional review process.

  • Who manufactures the MONITOR, ELECTROGRAPHIC and where is it distributed?

    The MONITOR, ELECTROGRAPHIC is manufactured by Medac, Inc. and distributed in the United States, with the company located in Wilsonville, Oregon.