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FDA 510(k)

DreamStation 2 System, DreamStation 2 Advanced System

K-Number: K200480 · 2020-07-10

ApplicantRespironics, Inc.
Decision Date2020-07-10
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DreamStation 2 System, DreamStation 2 Advanced System is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2020-07-10 under approval number K200480. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DreamStation 2 System, DreamStation 2 Advanced System?

DreamStation 2 System, DreamStation 2 Advanced System is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Respironics, Inc.. The 510(k) number is K200480.

When was DreamStation 2 System, DreamStation 2 Advanced System approved by the FDA?

DreamStation 2 System, DreamStation 2 Advanced System received FDA 510(k) clearance on 2020-07-10, under approval number K200480.

What company makes DreamStation 2 System, DreamStation 2 Advanced System?

DreamStation 2 System, DreamStation 2 Advanced System is manufactured by Respironics, Inc..

What is the FDA product code for DreamStation 2 System, DreamStation 2 Advanced System?

The FDA product code for DreamStation 2 System, DreamStation 2 Advanced System is BZD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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