510(k) K980551

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

K980551 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 17, 1998. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Nidek Medical Products, Inc. has at least 10 other 510(k) clearances on record.