510(k) K962492

SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM by Nidek Medical Products, Inc. — Product Code BYE

K962492 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 23, 1997. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Nidek Medical Products, Inc. has at least 10 other 510(k) clearances on record.