Clinical Neuro Syst Monitorr Ext CSF Drain/Moni Sy

FDA 510(k) K920156 · Clinical Neuro Systems, LLC

Substantially Equivalent

510(k) numberK920156

Submission

Device name
Clinical Neuro Syst Monitorr Ext CSF Drain/Moni Sy
Applicant
Clinical Neuro Systems, LLC
Goleta, CA, US
Received
January 14, 1992
Decision date
March 16, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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Questions and answers

When was Clinical Neuro Syst Monitorr Ext CSF Drain/Moni Sy cleared by the FDA?

Clinical Neuro Syst Monitorr Ext CSF Drain/Moni Sy (K920156) received a 510(k) decision of Substantially Equivalent on March 16, 1992, 62 days after the submission was received.

What is the product code of K920156?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.