510(k) Report

Devices descending from K070594

12 later devices reach Palmtop Ventilator, Models PTV-8, PTV-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+1K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+1K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc.20092Class I
+2K233486731 Series VentilatorZOLL Medical Corporation20240—
+2K181166Trilogy EvoRespironics, Inc.20195Class I
+2K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+2K111146Newport HT70 VentilatorNewport Medical Instruments, Inc.20111Class I
+3K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+3K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+3K240807VM-2000Ventis Medical, Inc.20240—
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+4K233452Vivo 45 LSBreas Medical AB202501