FDA 510(k)

AURA-PSG

K-Number: K050425 · 2005-10-20

Decision Date2005-10-20

Product CodeOLV

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AURA-PSG is the device name listed in this FDA 510(k) record. The listed applicant is Astro-Med, Inc.. It received FDA 510(k) clearance on 2005-10-20 under 510(k) number K050425. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURA-PSG?

AURA-PSG is a medical device that received FDA 510(k) clearance on 2005-10-20. The listed applicant is Astro-Med, Inc.. The 510(k) number is K050425.

When did AURA-PSG receive FDA 510(k) clearance?

AURA-PSG received FDA 510(k) clearance on 2005-10-20, under 510(k) number K050425.

Who is the listed applicant for AURA-PSG?

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

What is the FDA product code for AURA-PSG?

The FDA product code for AURA-PSG is OLV.

Other records listing Astro-Med, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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