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F&P Visairo NIV Mask Range

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203449
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Ltd
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
4/14/2021
Days to Decision
142 days
Submission Type
Summary

F&P Visairo NIV Mask Range

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203449
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Ltd
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
4/14/2021
Days to Decision
142 days
Submission Type
Summary