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FDA 510(k)

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM

K-Number: K130693 · 2013-08-14

ApplicantAseptico, Inc.
Decision Date2013-08-14
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aseptico, Inc.. It received FDA 510(k) clearance on 2013-08-14 under 510(k) number K130693. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM?

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-14. The listed applicant is Aseptico, Inc.. The 510(k) number is K130693.

When did AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM receive FDA 510(k) clearance?

AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM received FDA 510(k) clearance on 2013-08-14, under 510(k) number K130693.

Who is the listed applicant for AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM?

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

What is the FDA product code for AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM?

The FDA product code for AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM is ELC.

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Other records listing Aseptico, Inc. as applicant

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Related Devices (Code: ELC)

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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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