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RE1000 Heart Rate Monitor

by Electronic Monitors, Inc.

510(k) K822319

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 NumberK822319 Date14 Sep 1982ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The RE1000 Heart Rate Monitor is a Class II cardiac monitor, classified as a Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm). It is a device used for monitoring heart rate in cardiovascular applications.

It received FDA 510(k) clearance under K-number K822319 on September 14, 1982, with a substantially equivalent decision. The device is manufactured by Electronic Monitors, Inc. and is regulated under regulation number 870.2300 with product code DRT.

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