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FDA 510(k)

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE

K-Number: K131383 · 2013-11-27

ApplicantAdvanced Brain Monitoring, Inc.
Decision Date2013-11-27
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE 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 2013-11-27 under 510(k) number K131383. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE?

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-11-27. The listed applicant is Advanced Brain Monitoring, Inc.. The 510(k) number is K131383.

When did X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE receive FDA 510(k) clearance?

X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE received FDA 510(k) clearance on 2013-11-27, under 510(k) number K131383.

Who is the listed applicant for X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE?

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 X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE?

The FDA product code for X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE is GWQ.

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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 ProfilerK130007SLEEP PROFILERK130013X4 SYSTEMK120450SLEEP PROFILERK120447X4K112514APNEA RISK EVALUATION SYSTEM (ARES)

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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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