Skip to content

MUSE-DP

by Marquette Electronics, Inc.

510(k) K840932

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 NumberK840932 Date30 Oct 1984ClearedStatusActive

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  • Withdrawn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
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
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 MUSE-DP is a cardiovascular device identified by product code DXN. It received FDA 510(k) clearance as substantially equivalent through a traditional review process.

The device was cleared on October 30, 1984, under K840932, manufactured by Marquette Electronics, Inc. in Jupiter, Florida. It is authorized for distribution in the United States.

Other devices from Marquette Electronics, Inc.

See all devices from Marquette Electronics, Inc. →

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 MUSE-DP used for?

    The MUSE-DP is a cardiovascular device identified by product code DXN, intended for use in cardiovascular applications as determined by its FDA 510(k) clearance as substantially equivalent to a predicate device.

  • How was the MUSE-DP cleared for market?

    The MUSE-DP received FDA 510(k) clearance through a traditional review process, meaning it was evaluated for substantial equivalence to a legally marketed device, not through a clinical trial or premarket approval pathway.

  • When was the MUSE-DP cleared by the FDA?

    The MUSE-DP was cleared by the FDA on October 30, 1984, under submission number K840932, following receipt of the application on March 2, 1984.

  • Who manufactures the MUSE-DP and where is it made?

    The MUSE-DP is manufactured by Marquette Electronics, Inc., located in Jupiter, Florida, United States, with the address listed as P.O. Box 9100, 100 Marquette Dr., Jupiter, FL 33468.