FDA 510(k)

Aquilex Fluid Control System AQL-100S

K-Number: K172040 · 2018-02-05

Decision Date2018-02-05

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Aquilex Fluid Control System AQL-100S is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K172040. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquilex Fluid Control System AQL-100S?

Aquilex Fluid Control System AQL-100S is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K172040.

When did Aquilex Fluid Control System AQL-100S receive FDA 510(k) clearance?

Aquilex Fluid Control System AQL-100S received FDA 510(k) clearance on 2018-02-05, under 510(k) number K172040.

Who is the listed applicant for Aquilex Fluid Control System AQL-100S?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilex Fluid Control System AQL-100S?

The FDA product code for Aquilex Fluid Control System AQL-100S is HIG.

Other records listing W.O.M. World of Medicine GmbH as applicant

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Related Devices (Code: HIG)

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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.