FDA 510(k)

INTRACRANIAL PRESSURE MONITORING DEVICE

K-Number: K822864 · 1982-11-16

Decision Date1982-11-16

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

INTRACRANIAL PRESSURE MONITORING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K822864. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRACRANIAL PRESSURE MONITORING DEVICE?

INTRACRANIAL PRESSURE MONITORING DEVICE is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Medex, Inc.. The 510(k) number is K822864.

When did INTRACRANIAL PRESSURE MONITORING DEVICE receive FDA 510(k) clearance?

INTRACRANIAL PRESSURE MONITORING DEVICE received FDA 510(k) clearance on 1982-11-16, under 510(k) number K822864.

Who is the listed applicant for INTRACRANIAL PRESSURE MONITORING DEVICE?

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

What is the FDA product code for INTRACRANIAL PRESSURE MONITORING DEVICE?

The FDA product code for INTRACRANIAL PRESSURE MONITORING DEVICE is GWM.

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Related Devices (Code: GWM)

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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.