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Package For Medi-Trace Physiological Pre

by Graphic Controls Corp.

510(k) K801321

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 NumberK801321 Date30 Jun 1980ClearedStatusActive

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Package for Medi-Trace Physiological Pre is a medical device designed for use in physiological monitoring applications. It serves as a component for the Medi-Trace system to facilitate the collection of patient data.

This device is supplied by Graphic Controls Corp. and has received FDA 510(k) clearance under the reference number K801321. It is classified under product code DQO for use within cardiovascular clinical settings.

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Questions

AI-generated answers, 26 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 primary purpose of the Package for Medi-Trace Physiological Pre?

    This device is designed to function as a component within the Medi-Trace system. Its primary purpose is to facilitate the collection of patient data during physiological monitoring applications.

  • In what clinical environment is this device intended to be used?

    The device is classified under product code DQO, which indicates it is intended for use specifically within cardiovascular clinical settings to support patient monitoring.

  • What is the regulatory status of this device?

    The Package for Medi-Trace Physiological Pre has received FDA 510(k) clearance under reference number K801321. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.