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Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 510(k)

Active United States

510(k) K213825

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213825 Date28 Apr 2023ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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