FDA 510(k)

BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST

K-Number: K935659 · 1994-07-07

Decision Date1994-07-07

Product CodeFKX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST 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 1994-07-07 under 510(k) number K935659. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST?

BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST is a medical device that received FDA 510(k) clearance on 1994-07-07. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K935659.

When did BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST receive FDA 510(k) clearance?

BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST received FDA 510(k) clearance on 1994-07-07, under 510(k) number K935659.

Who is the listed applicant for BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST?

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 BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST?

The FDA product code for BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST is FKX.

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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.