Spiracle Technology - Model 302 Ox Inhalator

Q: What is the product code of K963755?

The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.

FDA 510(k) K963755 · Spiracle Technology

Substantially Equivalent

510(k) numberK963755

Submission

Device name: Spiracle Technology - Model 302 Ox Inhalator
Applicant: Spiracle Technology
Irvine, CA, US
Received: September 18, 1996
Decision date: April 8, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: CBP – Valve, Non-Rebreathing
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5870
Specialty: Anesthesiology
Life-sustaining: Yes

Other 510(k)s with product code CBP

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K241366	QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)CBP · Traditional	Dehas Medical Systems GmbH	10/29/2024SE
K234053	F&P Optiflow Flow DiverterCBP · Traditional	Fisher & Paykel Healthcare, Ltd.	08/09/2024SE
K210992	Altech® Exhalation Valve (Single Limb and Dual Limb)CBP · Traditional	Meditera Tibbi Malzeme San VE Tic AS	12/23/2021SE
K192285	CPR Face ShieldCBP · Traditional	Firstar Healthcare Company Limited (Guangzhou)	11/25/2020SE
K173770	OJR215 Pressure Relief ManifoldCBP · Traditional	Fisher & Paykel Healthcare Limited	04/05/2019SE
K171961	Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…CBP · Traditional	Xiamen Compower Medical Tech. Co., Ltd.	11/17/2017SE
K152521	Seal Rite Non-Rebreathing ValveCBP · Traditional	The Lifeguard Store, Inc.	06/03/2016SE
K142764	KYOLING CPR Mask with Oxygen Port and Without Oxygen PortCBP · Traditional	Hangzhou Jinlin Medical Appliances Co., Ltd.	07/09/2015SE
K142402	BigEasy Non-Rebreathing ValveCBP · Traditional	12th Man Technologies, Inc.	03/23/2015SE
K132143	Exhalation ValveCBP · Traditional	Intersurgical Incorporated	06/04/2014SE

More from Intersurgical Incorporated

510(k)	Device	Decision
K982225	Spiracle Technology-Bi-Flow Demand/Resuscitator Valve, Model 504BTL · Traditional	10/28/1998SE
K973347	TSX PRM Pulmonary Resuscitation MonitorCAP · Traditional	07/23/1998SE
K953349	Spiracle Technoloty Gaseous Oxygen Supply ValveCBP · Traditional	02/29/1996SE

Questions and answers

When was Spiracle Technology - Model 302 Ox Inhalator cleared by the FDA?

Spiracle Technology - Model 302 Ox Inhalator (K963755) received a 510(k) decision of Substantially Equivalent on April 8, 1997, 202 days after the submission was received.

What is the product code of K963755?

The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.