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Mingograf 410

by Siemens Medical Solutions USA, Inc.

510(k) K864009

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 NumberK864009 Date12 Jan 1987ClearedStatusActive

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  • Withdrawn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
DPS
Device class
Class II
Regulation
21 CFR Part 870.2340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Mingograf 410 is a cardiovascular device used for diagnostic monitoring. It is designed to record physiological signals to assist in clinical assessment.

This device is authorized under FDA 510(k) clearance K864009. It is manufactured by Siemens Medical Solutions USA, Inc. and is classified under product code DPS.

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Questions

AI-generated answers, 24 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 function of the Mingograf 410?

    The Mingograf 410 is a cardiovascular device engineered for diagnostic monitoring. Its primary purpose is to record physiological signals, which assists clinicians in performing accurate clinical assessments.

  • What is the regulatory status of this device?

    The Mingograf 410 is authorized under FDA 510(k) clearance, specifically identified by K-number K864009. This indicates that the device has been found substantially equivalent to a predicate device through the traditional 510(k) submission process.

  • Who is the manufacturer of the Mingograf 410?

    The Mingograf 410 is manufactured by Siemens Medical Solutions USA, Inc., located in Iselin, New Jersey. The device is classified under product code DPS within the cardiovascular advisory committee category.