Skip to content

Novametrix Model 505 Pulse Oximeter

by Novametrix Medical Systems, Inc.

510(k) K873078

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 NumberK873078 Date23 Sep 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  • Withdrawn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
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Novametrix Model 505 Pulse Oximeter is a device used for non-invasive measurement of arterial oxygen saturation and pulse rate. It functions by transmitting light through tissue and detecting changes in light absorption to determine oxygen saturation levels in the blood.

This device is supplied as a reusable medical instrument intended for use in clinical settings such as hospitals and medical facilities. It received FDA 510(k) clearance under product code DQA, with a determination of substantial equivalence, and is authorized for marketing in the United States.

Other devices from Novametrix Medical Systems, Inc.

See all devices from Novametrix Medical Systems, Inc. →