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Physio Gas Analyzer

by Research Medical, Inc.

510(k) K843423

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 NumberK843423 Date26 Feb 1985ClearedStatusActive

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  • Withdrawn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
LLL
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
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 Physio Gas Analyzer is a medical device used for gas analysis in physiological applications. It is designed to measure and analyze gas compositions in laboratory or clinical settings.

The device is manufactured by Research Medical, Inc. and has FDA 510K authorization with K number K843423. It is supplied as a Class II medical device and is intended for use in immunology applications. No specific information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.

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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 Physio Gas Analyzer used for?

    The Physio Gas Analyzer is a medical device designed to measure and analyze gas compositions in laboratory or clinical settings, specifically for immunology applications.

  • What is the regulatory status of the Physio Gas Analyzer?

    The Physio Gas Analyzer has FDA 510K authorization with K number K843423 and is classified as a Class II medical device, manufactured by Research Medical, Inc.

  • Is the Physio Gas Analyzer supplied as a single-use or reusable device?

    The device data does not specify whether the Physio Gas Analyzer is single-use or reusable, nor does it provide information on sterility, MRI safety, sizes, or storage conditions.

  • What advisory committee reviewed the Physio Gas Analyzer?

    The Physio Gas Analyzer was reviewed by the Immunology (IM) advisory committee, which specializes in devices related to immunology applications.