FDA 510(k) Applications Submitted by TRACOE MEDICAL GMBH

FDA 510(k) Number Submission Date Device Name Applicant
K172720 09/08/2017 TRACOE silcosoft Tracheostomy Tube TRACOE medical GmbH
K961449 04/16/1996 TRACHEOSTOMY TUBES TRACOE-FLEX TRACOE MEDICAL GMBH
K203362 11/16/2020 TRACOE vario TRACOE medical GmbH
K051587 06/15/2005 TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 TRACOE MEDICAL GMBH
K043160 11/15/2004 TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO TRACOE MEDICAL GMBH
K152778 09/25/2015 TRACOE Cuff Pressure Monitor TRACOE MEDICAL GMBH
K152865 09/30/2015 TRACOE smart Cuff Manager TRACOE MEDICAL GMBH


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