510(k) Report

Devices descending from K821568

5 later devices reach Blow-Singer Tracheostoma Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043138Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134Atos Medical AB20040—
+1K022125Provox Freehands Hme, Model 7710Atos Medical AB20022—
+1K013728Trach VoxEngineered Medical Systems20020—
+2K141380Provox Freehands FlexivoiceAtos Medical AB20140—
+2K072582Provox Micron HmeAtos Medical AB20080—