Ventricular Pressure Monitoring Kit, Model 110-4HM

Q: What is the product code of K914735?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.

FDA 510(k) K914735 · Camino Laboratories, Inc.

Substantially Equivalent

510(k) numberK914735

Submission

Device name: Ventricular Pressure Monitoring Kit, Model 110-4HM
Applicant: Camino Laboratories, Inc.
San Diego, CA, US
Received: October 21, 1991
Decision date: January 17, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GWM – Device, Monitoring, Intracranial Pressure
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1620
Specialty: Neurology

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More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.

510(k)	Device	Decision
K932769	Camino Ventricular Drainage SystemJXG · Traditional	03/30/1995SE
K930222	Camino Ventricular Access DeviceJXG · Traditional	04/15/1993SE
K930221	Camino Ventricular Transducer AccessoryGWM · Traditional	04/15/1993SE
K920088	Camino Ventricular NeedleHCD · Traditional	05/01/1992SE
K912833	Camino Model M420: Monit Inter W/Mean Pres DisplayDSK · Traditional	09/23/1991SE
K893232	Model V420 Direct Pressure Monitor & 427 WaveformDSK · Traditional	07/14/1989SE
K881183	Ventricular Bolt Pressure Monitoring Kit #110-4HGWM · Traditional	05/04/1988SE
K863969	Camino Compartmental Press Monitor CATH/110-4DDXO · Traditional	05/27/1987SE
K861961	Camino CSF Drainage System Model 040JXG · Traditional	08/12/1986SE
K862160	Camino Hand Drill - Model 030HBG · Traditional	07/18/1986SE

Questions and answers

When was Ventricular Pressure Monitoring Kit, Model 110-4HM cleared by the FDA?

Ventricular Pressure Monitoring Kit, Model 110-4HM (K914735) received a 510(k) decision of Substantially Equivalent on January 17, 1992, 88 days after the submission was received.

What is the product code of K914735?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.