Curve Positive Airway Pressure System

Positive Airway Pressure System

FRESCA Medical

The following data is part of a De Novo classification by Fresca Medical with the FDA for Curve Positive Airway Pressure System.

Pre-market Notification Details

DeNovo IDDEN170089
Device Name:Curve Positive Airway Pressure System
ClassificationPositive Airway Pressure System
Applicant FRESCA Medical 1291 Puerta Del Sol, Suite 200 San Clemente,  CA  92673
ContactMary Lou Mooney
Product CodeQBY  
CFR Regulation Number868.5273 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardAnesthesiology
Classification AdvisoryAnesthesiology
Date Received2017-12-14
Decision Date2018-06-05
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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