510(k) Report

Devices descending from K103211

5 later devices reach Avea Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+1K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+2K233486731 Series VentilatorZOLL Medical Corporation20240—
+2K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+3K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I