510(k) K952966

CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM by Nidek Medical Products, Inc. — Product Code BZD

K952966 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 7, 1996. 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.