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Vitalog PMS-8 Monitor

by Vitalog Corp.

510(k) K812739

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 NumberK812739 Date29 Dec 1981ClearedStatusActive

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  • Withdrawn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
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
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.

The Vitalog PMS-8 Monitor is a Class II cardiac pacemaker designed for monitoring and assessing cardiac function. As a device classified under the cardiovascular category, it is intended for use in clinical settings to evaluate heart rhythm and pacing performance in patients with implanted pacemakers.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K812739) with a product code of DQK. It was cleared as substantially equivalent (SESE) in 1981 and is intended for use in cardiovascular monitoring environments. No specific sterility or MRI safety information is provided in the available data.

Other devices from Vitalog Corp.

Questions

AI-generated answers, 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.

  • What is the Vitalog PMS-8 Monitor used for?

    The Vitalog PMS-8 Monitor is designed specifically for clinical use in cardiovascular settings. It evaluates and assesses cardiac function by monitoring heart rhythm and pacing performance in patients who have implanted pacemakers. This helps clinicians diagnose and manage arrhythmias or pacing-related issues.

  • Is the Vitalog PMS-8 Monitor reusable or single-use?

    The Vitalog PMS-8 Monitor is supplied as a reusable medical instrument. Reusability is common for monitoring devices like this, as they are typically cleaned, disinfected, and maintained between uses to ensure consistent performance and infection control.

  • What regulatory clearance does the Vitalog PMS-8 Monitor hold?

    The Vitalog PMS-8 Monitor holds FDA 510(k) clearance under the reference number K812739. It was classified as substantially equivalent (SESE) in 1981 and falls under the cardiovascular category (product code DQK). This clearance indicates it meets regulatory standards for safety and effectiveness.

  • Are there any specific sterility or MRI safety details provided for the Vitalog PMS-8 Monitor?

    The available data for the Vitalog PMS-8 Monitor does not include specific information regarding sterility requirements or MRI safety. Clinicians should follow standard protocols for reusable medical devices, including cleaning and disinfection, and consult manufacturer guidelines for MRI compatibility if needed.

  • What type of clinical environment is the Vitalog PMS-8 Monitor intended for?

    The Vitalog PMS-8 Monitor is intended for use in clinical settings focused on cardiovascular monitoring. This includes hospitals, cardiac care units, or electrophysiology labs where patients with implanted pacemakers require ongoing assessment of their heart rhythm and pacing functionality.