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Rhythmscan Precision 6000

by Precision Health Care Systems, Inc.

510(k) K914577

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 NumberK914577 Date8 May 1992ClearedStatusActive

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  • Withdrawn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
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Rhythmscan Precision 6000 is a device substantially equivalent to others in its class, as determined by the FDA. It falls under the product code DQK and is classified by the advisory committee as a cardiovascular device.

The device is supplied by Precision Health Care Systems, Inc. and has been granted FDA 510(k) clearance, as indicated by the k number K914577. The device is used in a medical setting, but specific details on its use, sterility, and storage are not provided. It is associated with the FDA clearance date of May 8, 1992.

Questions

AI-generated answers, 28 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 Rhythmscan Precision 6000 used for?

    The Rhythmscan Precision 6000 is used in a medical setting, specifically for cardiovascular purposes, as classified by the advisory committee.

  • Is the Rhythmscan Precision 6000 sterile?

    Specific details on the sterility of the Rhythmscan Precision 6000 are not provided, it is recommended to consult the manufacturer or device documentation for more information.

  • What is the regulatory status of the Rhythmscan Precision 6000?

    The Rhythmscan Precision 6000 has been granted FDA 510(k) clearance, as indicated by the k number K914577, and is classified as substantially equivalent to others in its class.