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The iNAP One Sleep Therapy System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193460
510(k) Type
Traditional
Applicant
Somnice, Inc.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
5/26/2020
Days to Decision
162 days
Submission Type
Summary

The iNAP One Sleep Therapy System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193460
510(k) Type
Traditional
Applicant
Somnice, Inc.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
5/26/2020
Days to Decision
162 days
Submission Type
Summary