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Onera Sleep Test System (Onera STS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223573
510(k) Type
Traditional
Applicant
Onera B.V.
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
8/18/2023
Days to Decision
261 days
Submission Type
Summary

Onera Sleep Test System (Onera STS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223573
510(k) Type
Traditional
Applicant
Onera B.V.
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
8/18/2023
Days to Decision
261 days
Submission Type
Summary