510(k) K043160

TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO by Tracoe Medical GmbH — Product Code JOH

K043160 is an FDA 510(k) premarket notification submitted by Tracoe Medical GmbH for the device "TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO". The FDA issued a decision of Substantially Equivalent on February 18, 2005. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Tracoe Medical GmbH has at least 7 other 510(k) clearances on record.