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FDA 510(k)

HF-100 DIALYZER

K-Number: K802092 · 1980-12-18

ApplicantBio-Med Corp.
Decision Date1980-12-18
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HF-100 DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Corp.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802092. 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 HF-100 DIALYZER?

HF-100 DIALYZER is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Bio-Med Corp.. The 510(k) number is K802092.

When did HF-100 DIALYZER receive FDA 510(k) clearance?

HF-100 DIALYZER received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802092.

Who is the listed applicant for HF-100 DIALYZER?

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

What is the FDA product code for HF-100 DIALYZER?

The FDA product code for HF-100 DIALYZER is FJI.

Related Clinical Trials

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.

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Other records listing Bio-Med Corp. as applicant

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.

K823286MODELS DPT 1000/DPT 1000NSK810735DISPOSABLE, STERILE TRANSDUCER DOMESK801985BIO-MED CORP. DISP. NON-STERILE TRANSDUK802069DISP. TRANSDUCER DOMES TD200 & TD300

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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