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F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190713
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Ltd.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
10/11/2019
Days to Decision
206 days
Submission Type
Summary

F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190713
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Ltd.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
10/11/2019
Days to Decision
206 days
Submission Type
Summary