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SomnaPatch

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183625
510(k) Type
Traditional
Applicant
Respironics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/18/2019
Days to Decision
296 days
Submission Type
Summary

SomnaPatch

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183625
510(k) Type
Traditional
Applicant
Respironics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/18/2019
Days to Decision
296 days
Submission Type
Summary