Remcore Remote Controlled Oxygen Regulator

FDA 510(k) K060265 · Remcore, Inc.

Substantially Equivalent

510(k) numberK060265

Submission

Device name
Remcore Remote Controlled Oxygen Regulator
Applicant
Remcore, Inc.
Boston, MA, US
Received
February 1, 2006
Decision date
October 25, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CAN – Regulator, Pressure, Gas Cylinder
Device class
Class I (low risk)
Regulation
21 CFR 868.2700
Specialty
Anesthesiology

Other 510(k)s with product code CAN

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K162811MR Conditional CGA 870CAN · Traditional Essex Industries, Inc.03/02/2017SE
K080243Portable Oxygen Unit SCA900CAN · Traditional San Cheong Co. , Ltd.04/07/2009SE
K061785Cyl-Fil Oxygen SystemCAN · Traditional Responsive Respiratory, Inc.09/07/2006SE
K950777Oxygen RegulatorCAN · Traditional Mada Medical Products, Inc.04/14/1995SE
K942751Vanguard Series Gas RegulatorsCAN · Traditional Buckman Co., Inc.02/09/1995SE
K936187Lspi Pressure RegulatorCAN · Traditional Life Support Products, Inc.01/27/1994SE
K9320061500 Series RegulatorCAN · Traditional Precision Medical, Inc.10/25/1993SE
K921125Ambu Oxygen RegulatorCAN · Traditional Amg, LLC09/17/1992SE
K915154Gambro Engstrom Y Filter Pkg. Alone W/ Var.ModelsCAN · Traditional C.G.H. Medical, Inc.05/27/1992SE
K915505Regulator FlowmeterCAN · Traditional Lifeguard Medical Products, Inc.04/22/1992SE

Questions and answers

When was Remcore Remote Controlled Oxygen Regulator cleared by the FDA?

Remcore Remote Controlled Oxygen Regulator (K060265) received a 510(k) decision of Substantially Equivalent on October 25, 2006, 266 days after the submission was received.

What is the product code of K060265?

The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.