Propaq 102, 104, 106, 102EL, 104EL, 106EL

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914838 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options

  Class II

  FDA 510(k) K951246 Active Cleared 2 Feb 1996

• Propaq ECG Telemetry Option

  Class II

  FDA 510(k) K934711 Active Cleared 1 Sep 1994

• PAQ10 Paper Chart Recorder

  Class I

  FDA 510(k) K894607 Active Cleared 26 Oct 1989

• Model Acuity Central Station

  Class II

  FDA 510(k) K935846 Active Cleared 5 Dec 1994

• Acuity Central Station

  Class II

  FDA 510(k) K972121 Active Cleared 7 Nov 1997

• Propaq 106(Tm)

  Class II

  FDA 510(k) K884320 Active Cleared 27 Dec 1988

See all devices from Protocol Systems, Inc. →

• What are the Propaq 102, 104, and 106 series monitors used for?

  The Propaq 102, 104, 106, and EL series are physiological patient monitors designed for use in clinical settings. They provide continuous patient monitoring, which includes specific functions for arrhythmia detection and clinical alarm management.

• What is the regulatory status of these patient monitors?

  These monitors are authorized under FDA 510(k) clearance. This regulatory status indicates that the devices have been reviewed and found to be substantially equivalent to other legally marketed devices within the same cardiovascular classification.

• Where can I find instructions for the operation and maintenance of these devices?

  The specific operational requirements, including instructions for use, maintenance, and storage, are detailed in the manufacturer-provided user and service manuals. Clinicians should consult these documents to ensure the devices are operated according to the manufacturer's specifications.