510(k) Report

Devices descending from K083693

6 later devices reach PB 840 Ventilator System with Leak Compensation Option, Model 840 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103211Avea VentilatorCare Fusion20115Class I
+2K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+2K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+3K233486731 Series VentilatorZOLL Medical Corporation20240—
+3K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+4K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I