Oxygen Swivel Adapter (Plastic)

FDA 510(k) K924225 · Linjorel Products, Inc.

Substantially Equivalent

510(k) numberK924225

Submission

Device name
Oxygen Swivel Adapter (Plastic)
Applicant
Linjorel Products, Inc.
Pittsburg, CA, US
Received
August 21, 1992
Decision date
September 4, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZA – Connector, Airway (Extension)
Device class
Class I (low risk)
Regulation
21 CFR 868.5810
Specialty
Anesthesiology

Other 510(k)s with product code BZA

510(k)DeviceApplicantDecision
K083702Trach-AssistBZA · Traditional Mergenet Medical03/05/2009SE
K954383Sureloc Circuit ConnectorBZA · Traditional Polamedco, Inc.12/22/1995SE
K954197Disposable Flex TubeBZA · Traditional Engstrom Medical10/26/1995SE
K953786Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional Unicor, Inc.09/19/1995SE
K952824Neo-Link, Disposable Neonatal Air Way ConnectorBZA · Traditional Intertex Medical, Inc.07/20/1995SE
K951345Disposable Airway Connectors for Gas SamplingBZA · Traditional Catheter Research, Inc.04/14/1995SE
K944532Prima, Inc. Ventilator HosesBZA · Traditional Prima, Inc.12/02/1994SE
K944535Prima, Inc. Gas Sampling Lines and ConnectorsBZA · Traditional Prima, Inc.11/29/1994SE
K944534Prima, Inc. Connectors and Airway ExtensionsBZA · Traditional Prima, Inc.11/29/1994SE
K942392Airway Connector with Flex TubeBZA · Traditional Mallinckrodt Medical08/22/1994SE

Questions and answers

When was Oxygen Swivel Adapter (Plastic) cleared by the FDA?

Oxygen Swivel Adapter (Plastic) (K924225) received a 510(k) decision of Substantially Equivalent on September 4, 1992, 14 days after the submission was received.

What is the product code of K924225?

The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.