510(k) Report

Devices descending from K170367

1 later device reach Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve -… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191624F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionFisher & Paykel Healthcare Limited20200—