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FDA 510(k)

PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236

K-Number: K980656 · 1998-05-19

ApplicantBaxter Healthcare Corp
Decision Date1998-05-19
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 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 1998-05-19 under 510(k) number K980656. 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 PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236?

PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 is a medical device that received FDA 510(k) clearance on 1998-05-19. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K980656.

When did PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 receive FDA 510(k) clearance?

PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 received FDA 510(k) clearance on 1998-05-19, under 510(k) number K980656.

Who is the listed applicant for PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236?

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 PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236?

The FDA product code for PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 is KDI.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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