510(k) Report

Devices descending from K962534

2 later devices reach Thera-Mist Nebulizer Model-P3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141214Aquapak Nebulizer Adaptors/ReservoirsTeleflexmedical, Inc.20141—
+2K153010Hudson RCI AquaPak Sterile Prefilled NebulizersTeleflexmedical, Inc.20160—