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

Full-montage Standard Electroencephalograph

ADVANCED BRAIN MONITORING INC.

The following data is part of a premarket notification filed by Advanced Brain Monitoring Inc. with the FDA for X10 Headset With X-series Basic Software, X24 Headset With X-series Basic Software.

Pre-market Notification Details

• Device ID: K131383
• 510k Number: K131383
• Device Name: X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
• Classification: Full-montage Standard Electroencephalograph
• Applicant: ADVANCED BRAIN MONITORING INC. W324 S3649 COUNTY ROAD E Dousman, WI 53118
• Contact: Adrienne Lenz
• Correspondent: Adrienne Lenz; ADVANCED BRAIN MONITORING INC. W324 S3649 COUNTY ROAD E Dousman, WI 53118
• Product Code: GWQ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-05-14
• Decision Date: 2013-11-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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