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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 the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) 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. The listed applicant is Respironics, Inc.. The 510(k) number is K200480.

When did DreamStation 2 System, DreamStation 2 Advanced System receive FDA 510(k) clearance?

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

Who is the listed applicant for DreamStation 2 System, DreamStation 2 Advanced System?

The FDA 510(k) record lists Respironics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Respironics, Inc. as applicant

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Related Devices (Code: 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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