FDA 510(k)

MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM

K-Number: K022554 · 2002-08-23

Decision Date2002-08-23

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurosciences. It received FDA 510(k) clearance on 2002-08-23 under 510(k) number K022554. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM?

MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-23. The listed applicant is Integra Neurosciences. The 510(k) number is K022554.

When did MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM receive FDA 510(k) clearance?

MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM received FDA 510(k) clearance on 2002-08-23, under 510(k) number K022554.

Who is the listed applicant for MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM?

The FDA 510(k) record lists Integra Neurosciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM?

The FDA product code for MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM is JXG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.