Camino Single Parameter Monitor, Model SPM-1

Q: What is the product code of K031086?

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) K031086 · Integra Neurosciences

Substantially Equivalent

510(k) numberK031086

Submission

Device name: Camino Single Parameter Monitor, Model SPM-1
Applicant: Integra Neurosciences
San Diego, CA, US
Received: April 7, 2003
Decision date: May 14, 2003
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary 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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Questions and answers

When was Camino Single Parameter Monitor, Model SPM-1 cleared by the FDA?

Camino Single Parameter Monitor, Model SPM-1 (K031086) received a 510(k) decision of Substantially Equivalent on May 14, 2003, 37 days after the submission was received.

What is the product code of K031086?

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