Last synced on 24 March 2023 at 11:04 pm

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Ant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170367
510(k) Type
Traditional
Applicant
Fisher and Paykel Healthcare Limited
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
8/24/2017
Days to Decision
199 days
Submission Type
Summary

Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Ant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170367
510(k) Type
Traditional
Applicant
Fisher and Paykel Healthcare Limited
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
8/24/2017
Days to Decision
199 days
Submission Type
Summary