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SOMNOscreen plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201054
510(k) Type
Traditional
Applicant
Somnomedics GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
8/12/2020
Days to Decision
113 days
Submission Type
Summary

SOMNOscreen plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201054
510(k) Type
Traditional
Applicant
Somnomedics GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
8/12/2020
Days to Decision
113 days
Submission Type
Summary