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9267 SPO2 Athena Module

by S & W Medico Teknik

510(k) K940933

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 NumberK940933 Date29 Nov 1995ClearedStatusActive

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  • Withdrawn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 9267 Spo2 Athena Module is an oximeter designed for cardiovascular monitoring. It functions to measure oxygen saturation levels in patients.

This device is classified as an FDA class 2 medical device under regulation number 870.2700. It received FDA 510(k) clearance on November 29, 1995, under the traditional clearance type.

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Questions

AI-generated answers, 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.

  • What is the primary function of the 9267 Spo2 Athena Module?

    The 9267 Spo2 Athena Module is an oximeter specifically designed for cardiovascular monitoring. Its primary function is to measure oxygen saturation levels in patients to assist clinicians in assessing cardiovascular health.

  • What is the regulatory status of this device?

    The 9267 Spo2 Athena Module is classified as an FDA class 2 medical device under regulation number 870.2700. It received FDA 510(k) clearance on November 29, 1995, under the traditional clearance type.

  • Who is the manufacturer of the 9267 Spo2 Athena Module?

    The device is manufactured by S & W Medico Teknik, located in Albertslund, Denmark.