Last synced on 6 December 2024 at 11:05 pm

SleepStageML

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233438
510(k) Type
Traditional
Applicant
Beacon Biosignals, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2024
Days to Decision
147 days
Submission Type
Summary

SleepStageML

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233438
510(k) Type
Traditional
Applicant
Beacon Biosignals, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/8/2024
Days to Decision
147 days
Submission Type
Summary