Cerox

FDA 510(k) K131854 · Or-Nim Medical , Ltd.

Substantially Equivalent

510(k) numberK131854

Submission

Device name
Cerox
Applicant
Or-Nim Medical , Ltd.
Kfar Saba, IL
Received
June 21, 2013
Decision date
September 13, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 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
K150268CerOXDPW · Traditional 11/06/2015SE
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 (K131854) received a 510(k) decision of Substantially Equivalent on September 13, 2013, 84 days after the submission was received.

What is the product code of K131854?

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