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Omni 2 Oxygen System

by Sequal Technologies Co., Ltd. 510(k)

Active United States

510(k) K083163

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083163 Date20 Oct 2009ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0248-2020 FDA Class II initiated 16 Sep 2019

    There is an electronics control issue that causes the unit to not power on with battery power only.

Specification

510(k)

510(k) Number
FDA Product Code
CAW
FDA applicant
Sequal Technologies, Inc.
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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