FDA 510(k)

AURA

K-Number: K102984 · 2010-12-08

Decision Date2010-12-08

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AURA is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Limited. It received FDA 510(k) clearance on 2010-12-08 under 510(k) number K102984. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURA?

AURA is a medical device that received FDA 510(k) clearance on 2010-12-08. The listed applicant is Sdi Limited. The 510(k) number is K102984.

When did AURA receive FDA 510(k) clearance?

AURA received FDA 510(k) clearance on 2010-12-08, under 510(k) number K102984.

Who is the listed applicant for AURA?

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

What is the FDA product code for AURA?

The FDA product code for AURA is EBF.

Other records listing Sdi Limited 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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Related Devices (Code: EBF)

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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.