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Physiological Display System, Model 1000

by Novametrix Medical Systems, Inc.

510(k) K821720

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 NumberK821720 Date25 Jun 1982ClearedStatusActive

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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
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 Physiological Display System, Model 1000 is a Class II cardiac monitor, including cardiotachometer and rate alarm functions, as defined by its regulatory classification. It is designed for use in cardiovascular monitoring applications.

This device was cleared via the FDA 510(k) process under K-number K821720, with a decision date of June 25, 1982, and is manufactured by Novametrix Medical Systems, Inc. It is supplied as a non-sterile, reusable system intended for use in clinical settings, with no indication of single-use designation or MRI safety specifications in the provided data.

Other devices from Novametrix Medical Systems, Inc.

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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 Physiological Display System, Model 1000 used for?

    The Physiological Display System, Model 1000 is designed for use in cardiovascular monitoring applications, providing cardiac monitoring, cardiotachometer, and rate alarm functions as a Class II device cleared under FDA 510(k) K821720.

  • Is the Physiological Display System, Model 1000 sterile or single-use?

    The device is supplied as a non-sterile, reusable system intended for clinical settings, with no indication of single-use designation or sterility in the provided data, meaning it must be cleaned and reprocessed between uses according to hospital protocols.

  • How was the Physiological Display System, Model 1000 cleared for market?

    The device was cleared via the FDA 510(k) process under K-number K821720, with a decision date of June 25, 1982, and a decision code of SESE (Substantially Equivalent), based on its classification as a Class II cardiac monitor under product code DRT and regulation number 870.2300.