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FDA 510(k)

CENTRY 2000 DIALYSIS CONTROL UNIT

K-Number: K840680 · 1984-04-20

ApplicantCobe Laboratories, Inc.
Decision Date1984-04-20
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CENTRY 2000 DIALYSIS CONTROL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1984-04-20 under 510(k) number K840680. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRY 2000 DIALYSIS CONTROL UNIT?

CENTRY 2000 DIALYSIS CONTROL UNIT is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K840680.

When did CENTRY 2000 DIALYSIS CONTROL UNIT receive FDA 510(k) clearance?

CENTRY 2000 DIALYSIS CONTROL UNIT received FDA 510(k) clearance on 1984-04-20, under 510(k) number K840680.

Who is the listed applicant for CENTRY 2000 DIALYSIS CONTROL UNIT?

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

What is the FDA product code for CENTRY 2000 DIALYSIS CONTROL UNIT?

The FDA product code for CENTRY 2000 DIALYSIS CONTROL UNIT is KDI.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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