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Satlite Trans Portable Pulse Oximeter

by Datex Division Instrumentarium Corp. 510(k)

Active United States

510(k) K890753

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890753 Date22 Mar 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A Satlite Trans Portable Pulse Oximeter is a pulse oximeter device used for measuring oxygen saturation in the blood. It is a portable, non-invasive monitoring tool designed for continuous or spot-check assessment of arterial oxygen saturation and pulse rate.

This device is supplied as a reusable, non-sterile instrument intended for use in clinical settings such as hospitals and medical facilities. It has received FDA 510(k) clearance (K890753) and is classified as a Class II medical device under product code DQA, with a decision of substantially equivalent to a legally marketed predicate device.

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