510(k) K920156

CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY by Clinical Neuro Systems, LLC — Product Code JXG

K920156 is an FDA 510(k) premarket notification submitted by Clinical Neuro Systems, LLC for the device "CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY". The FDA issued a decision of Substantially Equivalent on March 16, 1992. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Clinical Neuro Systems, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1992
Date Received
January 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type