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NR2000 Cardiac Monitor

by Nirad, Ltd.

510(k) K883903

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 NumberK883903 Date9 Mar 1989ClearedStatusActive

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  • Withdrawn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
FDA applicant
Nirad , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
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 NR2000 Cardiac Monitor is a cardiovascular device designed for monitoring cardiac activity. It is substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

The device is supplied by Nirad, Ltd. and was cleared through the traditional 510(k) pathway with K number K883903. It is authorized for use in the United States under FDA regulation.

Other devices from Nirad, Ltd.

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 NR2000 Cardiac Monitor used for?

    The NR2000 Cardiac Monitor is designed for monitoring cardiac activity as a cardiovascular device, based on its FDA 510(k) clearance as substantially equivalent to a predicate device.

  • How is the NR2000 Cardiac Monitor supplied and by whom?

    The device is supplied by Nirad, Ltd., located at Enkalon Industrial Estate, 25 Randlestown Rd., Antrim Co. Antrim, BT41 4LJ, Ireland, as indicated in the manufacturer and address details.

  • What regulatory pathway was used for the NR2000 Cardiac Monitor?

    The NR2000 Cardiac Monitor was cleared through the traditional 510(k) pathway under FDA regulation, with K number K883903 and decision date of March 9, 1989, confirming its substantially equivalent status.