Qflow 500 Perfusion Monitoring System

Q: What is the product code of K013376?

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

FDA 510(k) K013376 · Hemedex Incorporated

Substantially Equivalent

510(k) numberK013376

Submission

Device name: Qflow 500 Perfusion Monitoring System
Applicant: Hemedex Incorporated
Hopkonton, MA, US
Received: October 11, 2001
Decision date: May 8, 2002
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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K223843	FloPatch FP120DPW · Traditional	Flosonics Medical	05/03/2023SE
K222242	FloPatch FP120DPW · Traditional	Flosonics Medical	12/09/2022SE
K213974	GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special	Synovis Micro Companies Alliance, Inc.	04/20/2022SE
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More from Remington Medical, Inc.

510(k)	Device	Decision
K141869	Qflow 500 Titanium Bolt, Quad Lumen Bolt KitGWM · Traditional	10/10/2014SE
K032127	Hemedex Fixation DeviceKNY · Traditional	12/30/2003SE
K032337	Hemedex Cranial Bolt Models, 3601, 3602GWM · Traditional	10/21/2003SE

Questions and answers

When was Qflow 500 Perfusion Monitoring System cleared by the FDA?

Qflow 500 Perfusion Monitoring System (K013376) received a 510(k) decision of Substantially Equivalent on May 8, 2002, 209 days after the submission was received.

What is the product code of K013376?

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