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Healthdyne's Apnea/Heart Monitor, Model 900S

by Healthdyne, Inc.

510(k) K892006

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 NumberK892006 Date23 May 1989ClearedStatusActive

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  • Withdrawn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, 27 Sep 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 cardiac monitor, specifically a Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), as defined by its device type and nomenclature. It is designed to monitor apnea and heart activity, providing cardiotachometer and rate alarm functions.

It is a Class II device cleared via the FDA 510(k) pathway under clearance K892006, with product code DRT and regulation number 870.2300. The device is used in cardiovascular settings and was first cleared in 1989.

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Questions

AI-generated answers, 27 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 Healthdyne Model 900S used for?

    The Healthdyne Model 900S is designed to monitor apnea and heart activity, providing cardiotachometer and rate alarm functions as a cardiac monitor in cardiovascular settings.

  • How is the Healthdyne Model 900S supplied or configured for use?

    The device is supplied as a standalone cardiac monitor unit intended for use in clinical cardiovascular environments to continuously monitor cardiac rate and detect apnea events.

  • Is the Healthdyne Model 900S intended for single-use or repeated use?

    The Healthdyne Model 900S is a reusable cardiac monitor designed for repeated clinical use, not a single-use device, based on its classification and intended function as a monitoring system.