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FDA 510(k)

STARDUST II

K-Number: K052573 · 2005-12-13

ApplicantRespironics, Inc.
Decision Date2005-12-13
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STARDUST II is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2005-12-13 under 510(k) number K052573. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARDUST II?

STARDUST II is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Respironics, Inc.. The 510(k) number is K052573.

When did STARDUST II receive FDA 510(k) clearance?

STARDUST II received FDA 510(k) clearance on 2005-12-13, under 510(k) number K052573.

Who is the listed applicant for STARDUST II?

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 STARDUST II?

The FDA product code for STARDUST II is MNR.

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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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