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Holta-Med Recorder

by Holta-Med

510(k) K832395

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 NumberK832395 Date20 Oct 1983ClearedStatusActive

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  • Withdrawn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
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Holta-Med Recorder is a Recorder, Magnetic Tape, Medical device, designed to record and playback physiological signals from sources such as amplifiers, signal conditioners, or computers. It functions as a magnetic tape-based data storage and retrieval system for cardiovascular monitoring applications, enabling long-term archival and analysis of diagnostic data.

This device is supplied as a reusable medical instrument, intended for use in clinical settings where cardiovascular signal recording is required. It operates under FDA 510(k) clearance (K832395) and falls under Regulation 870.2800, classified as a Class II device. No specific sterility or MRI safety information is provided in the regulatory data, and its use is governed by the original submission details from 1983.

Other devices from Holta-Med

Questions

AI-generated answers, 19 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 Holta-Med Recorder primarily used for in clinical settings?

    The Holta-Med Recorder is designed to record and playback physiological signals, specifically for cardiovascular monitoring applications. It functions as a magnetic tape-based system to store and retrieve diagnostic data from sources like amplifiers or signal conditioners, enabling long-term archival and analysis of heart-related measurements.

  • Is the Holta-Med Recorder intended for single-use or reusable applications?

    The Holta-Med Recorder is explicitly described as a reusable medical instrument, intended for repeated use in clinical settings where cardiovascular signal recording is required.

  • What regulatory pathway was followed for the FDA clearance of the Holta-Med Recorder?

    The Holta-Med Recorder received FDA clearance through a traditional 510(k) submission (K832395), filed in 1983 under the Cardiovascular advisory committee. It was classified as substantially equivalent (SESE) and falls under regulation 870.2800 as a Class II device.

  • Are there any specific storage or handling requirements mentioned for the Holta-Med Recorder?

    The provided data does not include details about storage conditions, sterility, or special handling instructions for the Holta-Med Recorder. Since it is reusable, proper maintenance and cleaning protocols would likely be required, though these specifics are not documented in the regulatory submission.