Lundy Vaporizer System

FDA 510(k) K884090 · Vaporflow Technology, Inc.

Substantially Equivalent

510(k) numberK884090

Submission

Device name
Lundy Vaporizer System
Applicant
Vaporflow Technology, Inc.
Tustin, CA, US
Received
September 28, 1988
Decision date
January 24, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CAD – Vaporizer, Anesthesia, Non-Heated
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5880
Specialty
Anesthesiology

Other 510(k)s with product code CAD

510(k)DeviceApplicantDecision
K240375V80 Anesthetic Vaporizer (V80)CAD · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.10/31/2024SE
K172702Tec 820, Tec 850CAD · Traditional Datex-Ohmeda, Inc.01/04/2018SE
K150167V60 Anesthetic VaporizerCAD · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.06/30/2015SE
K110608Sevoflurane Vaporizer AdaptorCAD · Traditional Piramal Critcal Care, Inc (Formerly Minrad, Inc)07/20/2011SE
K060331Sigma Alpha VaporizerCAD · Traditional Penlon Limited05/10/2006SE
K053564Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454CAD · Traditional Penlon Limited03/03/2006SE
K051666Gav - General Anaesthetic VaporizerCAD · Traditional General Anaesthetic Services Limited08/23/2005SE
K042276D-VaporCAD · Traditional Draeger Medical, Inc.09/23/2004SE
K041076Delta TCAD · Special Penlon , Ltd.08/09/2004SE
K031027Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)CAD · Special Datex-Ohmeda, Inc.06/26/2003SE

Questions and answers

When was Lundy Vaporizer System cleared by the FDA?

Lundy Vaporizer System (K884090) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 118 days after the submission was received.

What is the product code of K884090?

The FDA product code is CAD – Vaporizer, Anesthesia, Non-Heated, a Class II (moderate risk) device regulated under 21 CFR 868.5880.