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FDA 510(k)

X4 SYSTEM

K-Number: K130013 · 2013-01-31

ApplicantAdvanced Brain Monitoring, Inc.
Decision Date2013-01-31
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

X4 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Brain Monitoring, Inc.. It received FDA 510(k) clearance on 2013-01-31 under 510(k) number K130013. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X4 SYSTEM?

X4 SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-31. The listed applicant is Advanced Brain Monitoring, Inc.. The 510(k) number is K130013.

When did X4 SYSTEM receive FDA 510(k) clearance?

X4 SYSTEM received FDA 510(k) clearance on 2013-01-31, under 510(k) number K130013.

Who is the listed applicant for X4 SYSTEM?

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

What is the FDA product code for X4 SYSTEM?

The FDA product code for X4 SYSTEM is OMC.

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Other records listing Advanced Brain Monitoring, Inc. as applicant

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.

K153412Sleep ProfilerK131383X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWAREK130007SLEEP PROFILERK120450SLEEP PROFILERK120447X4K112514APNEA RISK EVALUATION SYSTEM (ARES)

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Related Devices (Code: OMC)

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.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies SasK251726SignalNED System (Model RE)Forest Devices, Inc.K243185REMI Remote EEG Monitoring SystemEpitelK242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.

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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