Aerovent

FDA 510(k) K894969 · Monaghan Medical Corp.

Substantially Equivalent

510(k) numberK894969

Submission

Device name
Aerovent
Applicant
Monaghan Medical Corp.
Plattsburgh, NY, US
Received
August 7, 1989
Decision date
October 30, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

More from Mallinckrodt Medical

510(k)DeviceDecision
K220145Monaghan medical filtered mouthpiece kitCAF · Traditional 08/24/2023SE
K123945Strive Dual Zone Peak Flow MeterBZH · Traditional 04/17/2013SE
K110273Aerovent Plus CHCCAF · Traditional 06/09/2011SE
K031514Modification to Trupeak Peak Flow MeterBZH · Special 05/23/2003SE
K023097Truezone Peak Flow MeterBZH · Abbreviated 03/07/2003SE
K012939Aerovent II CHC Collapsible Holding ChamberCAF · Special 09/28/2001SE
K991212Modification to Truzone Peak Flow MeterBZH · Abbreviated 07/01/1999SE
K964130Aerogear Asthma Action KitBZH · Traditional 01/10/1997SE
K963089Truzone Peak Flow MeterBZH · Traditional 11/06/1996SE
K963095Trupeak Peak Flow MeterBZH · Traditional 11/04/1996SE

Questions and answers

When was Aerovent cleared by the FDA?

Aerovent (K894969) received a 510(k) decision of Substantially Equivalent on October 30, 1989, 84 days after the submission was received.

What is the product code of K894969?

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