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Ohmeda 7800 Anesthesia Ventilator Software Update

by Ohmeda Medical

510(k) K902084

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 NumberK902084 Date1 Oct 1990ClearedStatusActive

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  • Withdrawn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
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

This device is a continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. It is a software update for the Ohmeda 7800 anesthesia ventilator system.

The device is supplied as a software update for facility use and received FDA 510(k) clearance under K902084 on October 1, 1990. It is classified as a Class II medical device with product code CBK and regulation number 868.5895, and is intended for use in anesthesiology settings.

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