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Propaq ECG Telemetry Option

by Protocol Systems, Inc.

510(k) K934711

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 NumberK934711 Date1 Sep 1994ClearedStatusActive

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  • Withdrawn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
DRG
Device Class
Class II
Regulation
21 CFR Part 870.2910
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Propaq ECG Telemetry Option is a device that transmits and receives physiological signals, specifically ECG telemetry, using radiofrequency technology. It is designed for cardiovascular applications and is part of the Propaq series of monitoring systems.

This device is supplied as part of the Propaq monitoring system and is intended for use in clinical settings. It is a Class II device that received FDA 510(k) clearance in 1994 under product code DRG and regulation number 870.2910. The device is not specified as single-use or reusable, and no MRI safety information is provided in the data.

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Questions

AI-generated answers, 25 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 PROPAQ ECG Telemetry Option used for?

    The PROPAQ ECG Telemetry Option is designed to transmit and receive physiological signals, specifically ECG telemetry, using radiofrequency technology. It is intended for cardiovascular applications and is part of the Propaq series of monitoring systems used in clinical settings.

  • Is the PROPAQ ECG Telemetry Option single-use or reusable?

    The device data does not specify whether the PROPAQ ECG Telemetry Option is single-use or reusable. It is supplied as part of the Propaq monitoring system and is a Class II device that received FDA 510(k) clearance in 1994.

  • What regulatory approvals does the PROPAQ ECG Telemetry Option have?

    The PROPAQ ECG Telemetry Option is a Class II device that received FDA 510(k) clearance in 1994 under product code DRG and regulation number 870.2910. It was determined to be substantially equivalent to other devices on the market.

  • How is the PROPAQ ECG Telemetry Option supplied?

    The PROPAQ ECG Telemetry Option is supplied as part of the Propaq monitoring system. It is designed for use in clinical settings and integrates with the Propaq series of monitoring systems to provide cardiovascular monitoring capabilities.