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Clinical Neuro Syst Monitorr Ext Csf Drain/Moni Sy

by Clinical Neuro Systems, LLC

510(k) K920156

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920156 Date16 Mar 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1310-2019 FDA Class I initiated 8 Apr 2019

    The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JXG
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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