CerOX

FDA 510(k) K150268 · Or-Nim Medical , Ltd.

Substantially Equivalent

510(k) numberK150268

Submission

Device name
CerOX
Applicant
Or-Nim Medical , Ltd.
Kfar Saba, IL
Received
February 4, 2015
Decision date
November 6, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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More from Remington Medical, Inc.

510(k)DeviceDecision
K131854CeroxDPW · Special 09/13/2013SE
K100875Cerox, Model 321OFMUD · Traditional 01/25/2011SE
K093923Cerox Model 3210MUD · Special 01/19/2010SE
K073407PacificaMUD · Traditional 02/28/2008SE

Questions and answers

When was CerOX cleared by the FDA?

CerOX (K150268) received a 510(k) decision of Substantially Equivalent on November 6, 2015, 275 days after the submission was received.

What is the product code of K150268?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.