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X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152040
510(k) Type
Traditional
Applicant
ADVANCED BRAIN MONITORING, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2015
Days to Decision
100 days
Submission Type
Summary

X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152040
510(k) Type
Traditional
Applicant
ADVANCED BRAIN MONITORING, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/30/2015
Days to Decision
100 days
Submission Type
Summary