510(k) K962714

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 by Passy-Muir, Inc. — Product Code JOH

K962714 is an FDA 510(k) premarket notification submitted by Passy-Muir, Inc. for the device "PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000". The FDA issued a decision of Substantially Equivalent on Oct 28, 1996. The device falls under product code JOH (Tube Tracheostomy And Tube Cuff), a Class II device regulated under 21 CFR 868.5800. Passy-Muir, Inc. has at least 4 other 510(k) clearances on record.