Clinical Neuro Systems Monitorr Icp Lumbar Cathete

FDA 510(k) K922936 · Clinical Neuro Systems, LLC

Substantially Equivalent

510(k) numberK922936

Submission

Device name
Clinical Neuro Systems Monitorr Icp Lumbar Cathete
Applicant
Clinical Neuro Systems, LLC
Santa Barbara, CA, US
Received
June 18, 1992
Decision date
August 26, 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
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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More from Aesculap, Inc.

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K961113CNS Interchangeable Bit Cranial DrillHBG · Traditional 06/05/1996SE
K930229Clinical Neuro Systems Cranial DrillHBE · Traditional 03/16/1993SE
K922941Clinical Neuro Systems Monitorr Icp Ventricular CaJXG · Traditional 08/26/1992SE
K920156Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SyJXG · Traditional 03/16/1992SE

Questions and answers

When was Clinical Neuro Systems Monitorr Icp Lumbar Cathete cleared by the FDA?

Clinical Neuro Systems Monitorr Icp Lumbar Cathete (K922936) received a 510(k) decision of Substantially Equivalent on August 26, 1992, 69 days after the submission was received.

What is the product code of K922936?

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