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Carbostat CO2 Analyzer

by Elm Street Designs

510(k) K862559

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 NumberK862559 Date15 Jul 1986ClearedStatusActive

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  • Withdrawn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.

The Carbostat CO2 Analyzer is a medical device designed to measure carbon dioxide levels. It functions as an analytical instrument for monitoring gas concentrations in clinical environments.

This device is identified by K-number K862559 and has received FDA 510K clearance. It is categorized under the anesthesiology advisory committee for regulatory purposes.

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 Carbostat CO2 Analyzer?

    The Carbostat CO2 Analyzer is designed to serve as an analytical instrument for measuring carbon dioxide levels and monitoring gas concentrations within clinical environments.

  • What is the regulatory status of this device?

    The Carbostat CO2 Analyzer has received FDA 510K clearance under K-number K862559. It was determined to be substantially equivalent to existing devices and is categorized under the anesthesiology advisory committee.

  • Who is the manufacturer of the Carbostat CO2 Analyzer?

    The device is manufactured by Elm Street Designs, located in San Carlos, California.