Skip to content

Integra Oxygen Concentrators Model 6400-Om

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

Active United States

510(k) K003472

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003472 Date4 Jun 2001ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Sequal Technologies Co., Ltd.