Cleared Traditional

DreamStation 2 System, DreamStation 2 Advanced System

K200480 · Respironics, Inc. · Anesthesiology

Jul 2020

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K200480 is an FDA 510(k) clearance for the DreamStation 2 System, DreamStation 2 Advanced System, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 10, 2020, 134 days after receiving the submission on February 27, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K200480 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2020
Decision Date	July 10, 2020
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF