Skip to content

Type Expired CO2 9270, Capnograph

by S & W Medico Teknik

510(k) K895001

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 NumberK895001 Date22 Feb 1990ClearedStatusActive

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  • Withdrawn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
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
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.

This device is a capnograph designed to measure expired carbon dioxide (CO2) levels. It is used to monitor respiratory gas exchange by analyzing the concentration of CO2 in exhaled breath.

The device is supplied as a reusable instrument and was cleared through the FDA 510(k) process under K895001 with product code CCK. It was reviewed by the Anesthesiology advisory committee and received a substantially equivalent determination on February 22, 1990.

Other devices from S & W Medico Teknik A/S

See all devices from S & W Medico Teknik A/S →

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 TYPE EXPIRED CO2 9270 capnograph used for?

    This device measures expired carbon dioxide (CO2) levels in exhaled breath to monitor respiratory gas exchange, providing clinicians with real-time data on a patient's ventilation status during anesthesia or critical care.

  • Is the TYPE EXPIRED CO2 9270 capnograph reusable or single-use?

    The device is supplied as a reusable instrument, meaning it can be cleaned, disinfected, and used multiple times following the manufacturer's reprocessing instructions, reducing long-term costs compared to single-use alternatives.

  • How was the TYPE EXPIRED CO2 9270 capnograph cleared for market release?

    It received clearance through the FDA 510(k) process under submission K895001, with a substantially equivalent determination granted on February 22, 1990, after review by the Anesthesiology advisory committee.