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FDA 510(k)

DIALYZER, MAGNIFLO 100 PARALLEL PLATE

K-Number: K781966 · 1979-02-21

ApplicantErika, Inc.
Decision Date1979-02-21
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYZER, MAGNIFLO 100 PARALLEL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1979-02-21 under 510(k) number K781966. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYZER, MAGNIFLO 100 PARALLEL PLATE?

DIALYZER, MAGNIFLO 100 PARALLEL PLATE is a medical device that received FDA 510(k) clearance on 1979-02-21. The listed applicant is Erika, Inc.. The 510(k) number is K781966.

When did DIALYZER, MAGNIFLO 100 PARALLEL PLATE receive FDA 510(k) clearance?

DIALYZER, MAGNIFLO 100 PARALLEL PLATE received FDA 510(k) clearance on 1979-02-21, under 510(k) number K781966.

Who is the listed applicant for DIALYZER, MAGNIFLO 100 PARALLEL PLATE?

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

What is the FDA product code for DIALYZER, MAGNIFLO 100 PARALLEL PLATE?

The FDA product code for DIALYZER, MAGNIFLO 100 PARALLEL PLATE is FJG.

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Other records listing Erika, Inc. 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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Related Devices (Code: FJG)

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.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.

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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