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FDA 510(k)

3M AURORA SYSTEM

K-Number: K972355 · 1997-08-29

Applicant3M Company
Decision Date1997-08-29
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M AURORA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972355. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M AURORA SYSTEM?

3M AURORA SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is 3M Company. The 510(k) number is K972355.

When did 3M AURORA SYSTEM receive FDA 510(k) clearance?

3M AURORA SYSTEM received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972355.

Who is the listed applicant for 3M AURORA SYSTEM?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M AURORA SYSTEM?

The FDA product code for 3M AURORA SYSTEM is EBZ.

Related Clinical Trials

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.

Other records listing 3M Company 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.

View all 322 devices →

Related Devices (Code: EBZ)

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.

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.

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