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FDA 510(k)

CYBER 120 HEMODIALYZER

K-Number: K801377 · 1980-08-27

ApplicantCyberex Corp.
Decision Date1980-08-27
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CYBER 120 HEMODIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cyberex Corp.. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801377. 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 CYBER 120 HEMODIALYZER?

CYBER 120 HEMODIALYZER is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Cyberex Corp.. The 510(k) number is K801377.

When did CYBER 120 HEMODIALYZER receive FDA 510(k) clearance?

CYBER 120 HEMODIALYZER received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801377.

Who is the listed applicant for CYBER 120 HEMODIALYZER?

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

What is the FDA product code for CYBER 120 HEMODIALYZER?

The FDA product code for CYBER 120 HEMODIALYZER is FJG.

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 Cyberex 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.

K810837CYBER 80 HEMODIALYZERK802478CYBER 120 HEMODIALYZERK790824REPGREEN ULTRAFILTRATION MONITOR

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

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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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