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Blood Gas Expersystem 8700

by Medical Intelcom, Inc.

510(k) K833430

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833430 Date10 Feb 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LLE
Device Class
Class III
Advisory Committee
Unknown
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 Blood Gas Expersystem 8700 is a computer-based analyzer designed for blood gas analysis. It measures and evaluates key blood chemistry parameters, including oxygen, carbon dioxide, and pH levels, to assess respiratory and metabolic function in clinical settings.

This device is supplied as a standalone analyzer and is intended for use in clinical laboratories or hospital settings. It operates as a single-use or reusable system, depending on the consumables used, and is regulated under FDA 510(k) clearance (K833430) with a traditional review process. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.

Questions

AI-generated answers, 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.

  • What types of blood chemistry parameters does the Blood Gas Expersystem 8700 measure, and how might these help in clinical settings?

    The Blood Gas Expersystem 8700 measures oxygen, carbon dioxide, and pH levels, which are critical for assessing respiratory and metabolic function. These parameters help clinicians evaluate a patient’s acid-base balance, oxygenation status, and overall physiological stability—especially in critical care, emergency rooms, or hospital labs where rapid and accurate blood gas analysis is essential.

  • Is the Blood Gas Expersystem 8700 designed for single-use or reusable applications, and how does this affect its operation?

    The Blood Gas Expersystem 8700 can function as either a single-use or reusable system, depending on the consumables used. This flexibility allows clinical settings to choose based on workflow needs, cost efficiency, and infection control protocols. Reusable components may require proper cleaning and maintenance to ensure consistent performance and reliability.

  • How should the Blood Gas Expersystem 8700 be stored, and what precautions should be taken to maintain its accuracy?

    The Blood Gas Expersystem 8700 follows standard medical device storage protocols to preserve its accuracy and reliability. While specific details aren’t provided, general best practices include protecting it from extreme temperatures, humidity, and physical damage. Ensuring proper calibration and maintenance per manufacturer guidelines will help sustain performance in clinical environments.

  • What regulatory pathway was followed for FDA clearance of the Blood Gas Expersystem 8700, and what does this mean for its use in hospitals?

    The Blood Gas Expersystem 8700 received FDA clearance through a 510(k) submission (K833430) with a traditional review process, meaning it was determined to be substantially equivalent to a legally marketed device. This clearance allows its use in clinical laboratories and hospital settings for blood gas analysis, provided it adheres to the manufacturer’s instructions and regulatory requirements.