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FDA 510(k)

GALAXY

K-Number: K083874 · 2009-01-26

ApplicantRespironics Inc., Sleep & Home Respiratory Group
Decision Date2009-01-26
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GALAXY is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. It received FDA 510(k) clearance on 2009-01-26 under 510(k) number K083874. 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 GALAXY?

GALAXY is a medical device that received FDA 510(k) clearance on 2009-01-26. The listed applicant is Respironics Inc., Sleep & Home Respiratory Group. The 510(k) number is K083874.

When did GALAXY receive FDA 510(k) clearance?

GALAXY received FDA 510(k) clearance on 2009-01-26, under 510(k) number K083874.

Who is the listed applicant for GALAXY?

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

What is the FDA product code for GALAXY?

The FDA product code for GALAXY is MNR.

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Other records listing Respironics Inc., Sleep & Home Respiratory Group as applicant

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Related Devices (Code: 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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