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FDA 510(k)

AUSCO ES-3100

K-Number: K070550 · 2007-11-06

ApplicantKoratek Company, Ltd.
Decision Date2007-11-06
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUSCO ES-3100 is the device name listed in this FDA 510(k) record. The listed applicant is Koratek Company, Ltd.. It received FDA 510(k) clearance on 2007-11-06 under 510(k) number K070550. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUSCO ES-3100?

AUSCO ES-3100 is a medical device that received FDA 510(k) clearance on 2007-11-06. The listed applicant is Koratek Company, Ltd.. The 510(k) number is K070550.

When did AUSCO ES-3100 receive FDA 510(k) clearance?

AUSCO ES-3100 received FDA 510(k) clearance on 2007-11-06, under 510(k) number K070550.

Who is the listed applicant for AUSCO ES-3100?

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

What is the FDA product code for AUSCO ES-3100?

The FDA product code for AUSCO ES-3100 is DQD.

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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.

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