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Xenon Xe 127/Xe 133 Gas Dispenser

by Mallinckrodt Critical Care

510(k) K843640

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

Overview

A comprehensive medical device directory listing. This device is substantially equivalent to the decision_date: 1985-01-14 decision_description: Substantially Equivalent expedited_review_flag: Contact Thomas W Tusing for more information.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843640 Date14 Jan 1985ClearedStatusActive

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  • Withdrawn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
IYT
Device Class
Class II
Regulation
21 CFR Part 892.1390
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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