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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 the device name listed in this FDA 510(k) record. The listed applicant is Branchpoint Technologies, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) 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. The listed applicant is Branchpoint Technologies, Inc.. The 510(k) number is K172209.

When did AURA ICP MONITORING SYSTEM receive FDA 510(k) clearance?

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

Who is the listed applicant for AURA ICP MONITORING SYSTEM?

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

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

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

Related Devices (Code: GWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

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