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FDA 510(k)

IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS

K-Number: K991908 · 2000-04-17

ApplicantIdemsa
Decision Date2000-04-17
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Idemsa. It received FDA 510(k) clearance on 2000-04-17 under 510(k) number K991908. 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 IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS?

IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS is a medical device that received FDA 510(k) clearance on 2000-04-17. The listed applicant is Idemsa. The 510(k) number is K991908.

When did IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS receive FDA 510(k) clearance?

IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS received FDA 510(k) clearance on 2000-04-17, under 510(k) number K991908.

Who is the listed applicant for IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS?

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

What is the FDA product code for IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS?

The FDA product code for IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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