FDA 510(k)

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER

K-Number: K974652 · 1998-07-10

Decision Date1998-07-10

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1998-07-10 under 510(k) number K974652. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER?

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K974652.

When did BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER receive FDA 510(k) clearance?

BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER received FDA 510(k) clearance on 1998-07-10, under 510(k) number K974652.

Who is the listed applicant for BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER?

The FDA product code for BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER is KDI.

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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.