510(k) K990905

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT by Passy-Muir, Inc. — Product Code JOH

K990905 is an FDA 510(k) premarket notification submitted by Passy-Muir, Inc. for the device "PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT". The FDA issued a decision of Substantially Equivalent on Jun 11, 1999. 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.