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Modification To:Escort Vision Central Station Telemetry System, Model 20500

by Medical Data Electronics

510(k) K012336

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 · Special NumberK012336 Date3 Oct 2001ClearedStatusActive

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  • Withdrawn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
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
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.

This device is a modification to the Escort Vision Central Station Telemetry System, Model 20500, which is a detector and alarm system for arrhythmia. It is classified as a cardiovascular device and is intended for monitoring cardiac activity.

The system is supplied as a modification to the Escort Vision Central Station Telemetry System, Model 20500. It is a 510(k) cleared device and is not specified as single-use, reusable, sterile, or MRI safe. The device is stored at room temperature.

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