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FDA 510(k)

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234

K-Number: K980658 · 1998-05-19

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

Device Summary

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 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 K980658. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234?

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 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 K980658.

When did PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 receive FDA 510(k) clearance?

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 received FDA 510(k) clearance on 1998-05-19, under 510(k) number K980658.

Who is the listed applicant for PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234?

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 130/R5M4233, MODEL PSN-150/R5M4234?

The FDA product code for PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 is FJI.

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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