CPAP System and Broncho-Cath W/Cpap System

Q: What is the product code of K912240?

The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.

FDA 510(k) K912240 · Mallinckrodt Anesthesia Products

Substantially Equivalent

510(k) numberK912240

Submission

Device name: CPAP System and Broncho-Cath W/Cpap System
Applicant: Mallinckrodt Anesthesia Products
Argyle, NY, US
Received: May 21, 1991
Decision date: August 22, 1991
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: BYE – Attachment, Breathing, Positive End Expiratory Pressure
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5965
Specialty: Anesthesiology
Life-sustaining: Yes

Other 510(k)s with product code BYE

510(k)	Device	Applicant	Decision
K160112	Besmed PEEP ValveBYE · Traditional	Besmed Health Business Corp	04/29/2016SE
K133957	Disposable Adjustable Peep Valve MR Conditional UseBYE · Traditional	Galemed Corp.	04/14/2014SE
K133210	B&B BubblerBYE · Traditional	S & T Medical Technologies, Inc.	03/28/2014SE
K122610	Plaxtron CPAP System, Model CH-FFM-87XX/CH-FFM-88XX SeriesBYE · Traditional	Sen MU Technology Co., Ltd.	08/05/2013SE
K112546	O_Two CPAP SystemBYE · Traditional	O-Two Medical Technologies, Inc.	12/27/2011SE
K110713	Waterpap ValveBYE · Traditional	Airways Development, LLC	09/12/2011SE
K103833	Neopip Patient Circuit with PeepBYE · Traditional	Neoforce Group, Inc.	04/20/2011SE
K092029	Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional	Draeger Medical AG & Co. KG	08/06/2010SE
K090710	Mercury CPAPBYE · Traditional	Mercury Medical	08/20/2009SE
K090317	Babi*Plus Bubble Pap ValveBYE · Traditional	A Plus Medical	05/20/2009SE

More from A Plus Medical

510(k)	Device	Decision
K895875	Model 4070 Temperature MonitorFLL · Traditional	12/21/1989SE
K890484	Hi-Lo Temp General Purpose Temperature ProbeFLL · Traditional	04/21/1989SE

Questions and answers

When was CPAP System and Broncho-Cath W/Cpap System cleared by the FDA?

CPAP System and Broncho-Cath W/Cpap System (K912240) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 93 days after the submission was received.

What is the product code of K912240?

The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.