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FDA 510(k)

X4

K-Number: K120447 · 2012-06-20

ApplicantAdvanced Brain Monitoring, Inc.
Decision Date2012-06-20
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

X4 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 2012-06-20 under 510(k) number K120447. 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?

X4 is a medical device that received FDA 510(k) clearance on 2012-06-20. The listed applicant is Advanced Brain Monitoring, Inc.. The 510(k) number is K120447.

When did X4 receive FDA 510(k) clearance?

X4 received FDA 510(k) clearance on 2012-06-20, under 510(k) number K120447.

Who is the listed applicant for X4?

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?

The FDA product code for X4 is OMC.

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.

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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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