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FDA 510(k)

SHUNTCHECK - CSF SHUNT FLOW DETECTOR

K-Number: K080168 · 2008-05-16

ApplicantNeuro Diagnostic Devices
Decision Date2008-05-16
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SHUNTCHECK - CSF SHUNT FLOW DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Diagnostic Devices. It received FDA 510(k) clearance on 2008-05-16 under 510(k) number K080168. 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 SHUNTCHECK - CSF SHUNT FLOW DETECTOR?

SHUNTCHECK - CSF SHUNT FLOW DETECTOR is a medical device that received FDA 510(k) clearance on 2008-05-16. The listed applicant is Neuro Diagnostic Devices. The 510(k) number is K080168.

When did SHUNTCHECK - CSF SHUNT FLOW DETECTOR receive FDA 510(k) clearance?

SHUNTCHECK - CSF SHUNT FLOW DETECTOR received FDA 510(k) clearance on 2008-05-16, under 510(k) number K080168.

Who is the listed applicant for SHUNTCHECK - CSF SHUNT FLOW DETECTOR?

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

What is the FDA product code for SHUNTCHECK - CSF SHUNT FLOW DETECTOR?

The FDA product code for SHUNTCHECK - CSF SHUNT FLOW DETECTOR is JXG.

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Official Source

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

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