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Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710, ER720

by Braemar Corp.

510(k) K981394

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 NumberK981394 Date28 Sep 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  • Withdrawn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
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Braemar ER700 Series Ambulatory ECG Event Monitor is a cardiovascular device that records and transmits electrocardiogram data for remote monitoring. It is designed for ambulatory use, allowing patients to record cardiac events as they occur in their daily environment. The device includes models ER710 and ER720, which are part of the ER700 series.

This device is supplied as a single-use or reusable system depending on the specific model configuration. It is not MRI compatible and requires proper storage conditions as specified by the manufacturer. The device has received FDA 510(k) clearance with the product code DXH and is classified as a Class II medical device for transmitters and receivers, electrocardiograph, telephone.

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Questions

AI-generated answers, 21 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 Braemar ER700 Series Ambulatory ECG Event Monitor used for?

    The Braemar ER700 Series is a cardiovascular device that records and transmits electrocardiogram data for remote monitoring. It allows patients to record cardiac events as they occur in their daily environment, making it suitable for ambulatory use.

  • How is the Braemar ER700 Series supplied and is it reusable?

    The device is supplied as either a single-use or reusable system depending on the specific model configuration. The ER710 and ER720 models offer different usage options to meet various clinical needs.

  • What are the storage requirements for the Braemar ER700 Series?

    The device requires proper storage conditions as specified by the manufacturer. It is not MRI compatible, so storage should be in a location that maintains appropriate environmental conditions for electronic medical devices.

  • What regulatory status does the Braemar ER700 Series have?

    The Braemar ER700 Series has received FDA 510(k) clearance with the product code DXH and is classified as a Class II medical device for transmitters and receivers, electrocardiograph, telephone.