CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

Ventilator, Non-continuous (respirator)

NIDEK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Nidek Medical Products, Inc. with the FDA for Cp-90 Continuous Positive Airway Pressure System.

Pre-market Notification Details

Device IDK952966
510k NumberK952966
Device Name:CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
ClassificationVentilator, Non-continuous (respirator)
Applicant NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham,  AL  35217
ContactGregg Gaskins
CorrespondentGregg Gaskins
NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR Birmingham,  AL  35217
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-27
Decision Date1996-05-07

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