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F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173060
510(k) Type
Traditional
Applicant
Fisher and Paykel Healthcare Limited
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
1/25/2018
Days to Decision
119 days
Submission Type
Summary

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173060
510(k) Type
Traditional
Applicant
Fisher and Paykel Healthcare Limited
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
1/25/2018
Days to Decision
119 days
Submission Type
Summary