Vaporizer, Anesthesia, Non-Heated

FDA 510(k) K882500 · Anesthetic Vaporizer Services

Substantially Equivalent

510(k) numberK882500

Submission

Device name
Vaporizer, Anesthesia, Non-Heated
Applicant
Anesthetic Vaporizer Services
Clarence, NY, US
Received
June 17, 1988
Decision date
August 1, 1988
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 Vaporizer, Anesthesia, Non-Heated cleared by the FDA?

Vaporizer, Anesthesia, Non-Heated (K882500) received a 510(k) decision of Substantially Equivalent on August 1, 1988, 45 days after the submission was received.

What is the product code of K882500?

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