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Siemens FIO2 Sensor

by Siemens Medical Solutions USA, Inc.

510(k) K991884

Siemens FIO2 Sensor is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K991884 on 3 Nov 1999, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991884 Date3 Nov 1999ClearedStatusActive

Official records

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  • Withdrawn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
CCL
Device class
Class II
Regulation
21 CFR Part 868.1720
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K991884

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K991884
UDI-DISize and differences
FiO2 Sensor Cable, 1.5M 5597898
Draeger Medical Systems, Inc.
559789804049098008358 —On the market

Similar devices

Other devices filed under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase).

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