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Mdilog, Model Mdc-511

by Medtrak Technologies, Inc.

510(k) K970344

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 NumberK970344 Date6 Aug 1997ClearedStatusActive

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  • Withdrawn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
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 MDILOG, MODEL MDC-511 is a medical device that falls under the product code CAF. It is a device that has been determined to be substantially equivalent to other devices in its category.

The device is manufactured by Medtrak Technologies, Inc. and received FDA 510K clearance on August 6, 1997. It is reviewed by the Anesthesiology advisory committee and is intended for use in medical settings. The device is supplied as per the manufacturer's specifications and is subject to regulatory oversight.

Other devices from Medtrak Technologies, Inc.

Questions

AI-generated answers, 23 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 MDILOG MDC-511 device used for?

    The MDILOG MDC-511 is a medical device intended for use in medical settings, though specific indications are not detailed in the available information. It falls under product code CAF and has been determined to be substantially equivalent to other devices in its category.

  • How is the MDILOG MDC-511 supplied?

    The MDILOG MDC-511 is supplied according to the manufacturer's specifications. The device is manufactured by Medtrak Technologies, Inc. and is subject to regulatory oversight as a medical device.

  • What is the regulatory status of the MDILOG MDC-511?

    The MDILOG MDC-511 received FDA 510K clearance on August 6, 1997, with the K number K970344. It was reviewed by the Anesthesiology advisory committee and is classified under product code CAF.

  • Is the MDILOG MDC-511 a single-use or reusable device?

    The available information does not specify whether the MDILOG MDC-511 is designed for single-use or multiple uses. The device's sterility and reuse policy would need to be confirmed directly with the manufacturer or through the product documentation.