510(k) Report

Devices descending from K043160

3 later devices reach Tracoe Phon Assist I - Speaking Valves, Reference Models: Phon Assist… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+2K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+3K233713Pilling Tracheostomy TubesTeleflex Medical20240—