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As/3(Tm) Anesthesia Monitor Syst Interface Board

by Datex Division Instrumentarium Corp.

510(k) K935477

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 NumberK935477 Date1 Aug 1994ClearedStatusActive

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  • Withdrawn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, 23 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 AS/3 Anesthesia Monitor System Interface Board is a component of the AS/3 Anesthesia Monitor System, designed to interface with monitoring equipment in anesthesia settings. It serves as a connection point for various monitoring functions within the anesthesia system.

This device is supplied as a single-use or reusable component, depending on the specific application. It is manufactured by Datex Division Instrumentarium Corp. and has FDA 510K clearance with product code CCK. The device is intended for use in anesthesia monitoring systems and is available in various sizes as specified by the manufacturer.

Other devices from Datex Division Instrumentarium Corp.

See all devices from Datex Division Instrumentarium Corp. →

Questions

AI-generated answers, 23 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 AS/3 Anesthesia Monitor System Interface Board used for?

    The AS/3 Anesthesia Monitor System Interface Board is designed to interface with monitoring equipment in anesthesia settings, serving as a connection point for various monitoring functions within the anesthesia system.

  • Is the AS/3 Anesthesia Monitor System Interface Board single-use or reusable?

    The device is supplied as either a single-use or reusable component, depending on the specific application requirements as specified by the manufacturer.

  • What regulatory approvals does the AS/3 Anesthesia Monitor System Interface Board have?

    The device has FDA 510K clearance with product code CCK, indicating it has been determined to be substantially equivalent to existing devices in the market.

  • What sizes and models of the AS/3 Anesthesia Monitor System Interface Board are available?

    The device is available in various sizes as specified by the manufacturer, though specific dimensions or model variations are not detailed in the provided information.