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FDA 510(k)

AQUINOX

K-Number: K050314 · 2005-02-18

ApplicantSmiths Medical Asd, Inc.
Decision Date2005-02-18
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AQUINOX is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2005-02-18 under 510(k) number K050314. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUINOX?

AQUINOX is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K050314.

When did AQUINOX receive FDA 510(k) clearance?

AQUINOX received FDA 510(k) clearance on 2005-02-18, under 510(k) number K050314.

Who is the listed applicant for AQUINOX?

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

What is the FDA product code for AQUINOX?

The FDA product code for AQUINOX is BTT.

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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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