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FDA 510(k)

AURA ICP MONITORING SYSTEM

K-Number: K172209 · 2018-05-18

ApplicantBranchpoint Technologies, Inc.
Decision Date2018-05-18
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AURA ICP MONITORING SYSTEM is a medical device manufactured by Branchpoint Technologies, Inc.. It received FDA 510(k) clearance on 2018-05-18 under approval number K172209. 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 AURA ICP MONITORING SYSTEM?

AURA ICP MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Branchpoint Technologies, Inc.. The 510(k) number is K172209.

When was AURA ICP MONITORING SYSTEM approved by the FDA?

AURA ICP MONITORING SYSTEM received FDA 510(k) clearance on 2018-05-18, under approval number K172209.

What company makes AURA ICP MONITORING SYSTEM?

AURA ICP MONITORING SYSTEM is manufactured by Branchpoint Technologies, Inc..

What is the FDA product code for AURA ICP MONITORING SYSTEM?

The FDA product code for AURA ICP MONITORING SYSTEM is GWM.

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Related PubMed Literature

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Related Devices (Code: GWM)

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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.

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