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Revised Pneumatic Diagrams for Modulus II Plus

by Ohmeda Medical

510(k) K882489

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 NumberK882489 Date8 Jul 1988ClearedStatusActive

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  • Withdrawn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
BSZ
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Revised Pneumatic Diagrams for Modulus II Plus are diagrams used to illustrate the pneumatic system of the Modulus II Plus anesthesia machine. They provide a visual representation of the gas flow and connections within the device.

These diagrams are supplied as part of the device documentation and are intended for use by service personnel and operators. They are not sterile and are not intended for single use. The device is regulated under FDA 510(k) clearance K882489.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Revised Pneumatic Diagrams for Modulus II Plus used for?

    These diagrams provide a visual representation of the gas flow and connections within the Modulus II Plus anesthesia machine. They are intended for use by service personnel and operators to understand the device's pneumatic system.

  • Are these diagrams sterile?

    No, the Revised Pneumatic Diagrams for Modulus II Plus are not sterile. They are documentation intended for reference and are not intended for single use.

  • Who is the intended user for these diagrams?

    The diagrams are intended for use by service personnel and operators of the Modulus II Plus anesthesia machine.

  • How are the diagrams supplied?

    The diagrams are supplied as part of the device documentation.