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F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191624
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Limited
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
3/9/2020
Days to Decision
265 days
Submission Type
Summary

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191624
510(k) Type
Traditional
Applicant
Fisher & Paykel Healthcare Limited
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
3/9/2020
Days to Decision
265 days
Submission Type
Summary