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Pulse Oximeter (Model OHT60, OXH78)

by Cofoe Medical Technology Co., Ltd

510(k) K230277

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230277↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK230277 Date4 Jan 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DQA
FDA applicant
Cofoe Medical Technology Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Pulse Oximeter (Model OHT60, OXH78) is a non-invasive medical device designed to measure oxygen saturation levels in arterial blood (SpO₂) and pulse rate. It operates by emitting light through a patient’s finger, earlobe, or other perfused tissue and detecting the absorption differences to estimate hemoglobin oxygenation and heart rate.

This device is supplied as a single-use or reusable (depending on model) and is intended for use in clinical settings such as hospitals, emergency rooms, and patient monitoring environments. It complies with FDA 510(k) clearance under the Cardiovascular advisory committee and EU MDR requirements, with models OHT60 and OXH78 identified by their respective product codes. Sterility and MRI safety are not specified in the data.

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