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FDA 510(k)

STARDUST

K-Number: K973920 · 1998-05-14

ApplicantRespironics, Inc.
Decision Date1998-05-14
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STARDUST is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1998-05-14 under 510(k) number K973920. 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?

STARDUST is a medical device that received FDA 510(k) clearance on 1998-05-14. The listed applicant is Respironics, Inc.. The 510(k) number is K973920.

When did STARDUST receive FDA 510(k) clearance?

STARDUST received FDA 510(k) clearance on 1998-05-14, under 510(k) number K973920.

Who is the listed applicant for STARDUST?

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?

The FDA product code for STARDUST 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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