DreamStation 2 System, DreamStation 2 Advanced System

Ventilator, Non-continuous (respirator)

Respironics, Inc.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Dreamstation 2 System, Dreamstation 2 Advanced System.

Pre-market Notification Details

Device IDK200480
510k NumberK200480
Device Name:DreamStation 2 System, DreamStation 2 Advanced System
ClassificationVentilator, Non-continuous (respirator)
Applicant Respironics, Inc. 1001 Murry Ridge Lane Murrysville,  PA  15668
ContactAndy Zaltwanger
CorrespondentAndy Zaltwanger
Respironics, Inc. 1740 Golden Mile Highway Monroeville,  PA  15146
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-27
Decision Date2020-07-10

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