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FDA 510(k)

NIKKISO ND-14 PARALLEL FLOW DIALYZER

K-Number: K803068 · 1981-03-04

ApplicantNIKKISO CO., LTD.
Decision Date1981-03-04
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIKKISO ND-14 PARALLEL FLOW DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is NIKKISO CO., LTD.. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K803068. 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 NIKKISO ND-14 PARALLEL FLOW DIALYZER?

NIKKISO ND-14 PARALLEL FLOW DIALYZER is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is NIKKISO CO., LTD.. The 510(k) number is K803068.

When did NIKKISO ND-14 PARALLEL FLOW DIALYZER receive FDA 510(k) clearance?

NIKKISO ND-14 PARALLEL FLOW DIALYZER received FDA 510(k) clearance on 1981-03-04, under 510(k) number K803068.

Who is the listed applicant for NIKKISO ND-14 PARALLEL FLOW DIALYZER?

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

What is the FDA product code for NIKKISO ND-14 PARALLEL FLOW DIALYZER?

The FDA product code for NIKKISO ND-14 PARALLEL FLOW DIALYZER is FJG.

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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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