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ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202529
510(k) Type
Special
Applicant
ProSomnus Sleep Technologies, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/20/2020
Days to Decision
80 days
Submission Type
Summary

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202529
510(k) Type
Special
Applicant
ProSomnus Sleep Technologies, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/20/2020
Days to Decision
80 days
Submission Type
Summary