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F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200089
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Ltd.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
6/2/2020
Days to Decision
139 days
Submission Type
Summary

F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200089
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Ltd.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
6/2/2020
Days to Decision
139 days
Submission Type
Summary