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FDA 510(k)

DURQ/ QUALIDURA

K-Number: K013116 · 2002-01-18

ApplicantEver-Safety Technical Service
Decision Date2002-01-18
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DURQ/ QUALIDURA is the device name listed in this FDA 510(k) record. The listed applicant is Ever-Safety Technical Service. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K013116. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURQ/ QUALIDURA?

DURQ/ QUALIDURA is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Ever-Safety Technical Service. The 510(k) number is K013116.

When did DURQ/ QUALIDURA receive FDA 510(k) clearance?

DURQ/ QUALIDURA received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013116.

Who is the listed applicant for DURQ/ QUALIDURA?

The FDA 510(k) record lists Ever-Safety Technical Service as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURQ/ QUALIDURA?

The FDA product code for DURQ/ QUALIDURA is BTA.

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Related Devices (Code: BTA)

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.

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