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Heart Rate Computer

by Stanford Assoc., Inc.

510(k) K791862

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 NumberK791862 Date4 Oct 1979ClearedStatusActive

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  • Withdrawn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, 1 Oct 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 (Including Cardiotachometer and Rate Alarm), designed to measure and display heart rate. It functions as a standalone unit to provide continuous or intermittent monitoring of cardiac rhythm, aiding in the assessment of heart function during clinical evaluations or patient care settings.

The Heart Rate Computer is intended for use in cardiovascular settings, where precise heart rate measurement is required. It is classified as a Class II device under FDA regulation 870.2300 and was granted FDA 510(k) clearance (K791862) in 1979 under the Substantially Equivalent determination. No specific sterility or single-use/reusable designation is provided in the data, though its design suggests it may be intended for reusable clinical environments.

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