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FDA 510(k)

AQUAbase nX

K-Number: K223479 · 2023-08-16

ApplicantB.Braun Medical, Inc.
Decision Date2023-08-16
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AQUAbase nX is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K223479. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUAbase nX?

AQUAbase nX is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K223479.

When did AQUAbase nX receive FDA 510(k) clearance?

AQUAbase nX received FDA 510(k) clearance on 2023-08-16, under 510(k) number K223479.

Who is the listed applicant for AQUAbase nX?

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

What is the FDA product code for AQUAbase nX?

The FDA product code for AQUAbase nX is FIP.

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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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