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Transcend 365 miniCPAP System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180388
510(k) Type
Traditional
Applicant
Somnetics International, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/30/2018
Days to Decision
290 days
Submission Type
Summary

Transcend 365 miniCPAP System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180388
510(k) Type
Traditional
Applicant
Somnetics International, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/30/2018
Days to Decision
290 days
Submission Type
Summary