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FDA 510(k)

CONTINUOUS BLOOD PROCESSOR CBP-6000 &

K-Number: K820243 · 1982-03-25

ApplicantBentley Laboratories, Inc.
Decision Date1982-03-25
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS BLOOD PROCESSOR CBP-6000 & is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1982-03-25 under 510(k) number K820243. 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 CONTINUOUS BLOOD PROCESSOR CBP-6000 &?

CONTINUOUS BLOOD PROCESSOR CBP-6000 & is a medical device that received FDA 510(k) clearance on 1982-03-25. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K820243.

When did CONTINUOUS BLOOD PROCESSOR CBP-6000 & receive FDA 510(k) clearance?

CONTINUOUS BLOOD PROCESSOR CBP-6000 & received FDA 510(k) clearance on 1982-03-25, under 510(k) number K820243.

Who is the listed applicant for CONTINUOUS BLOOD PROCESSOR CBP-6000 &?

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

What is the FDA product code for CONTINUOUS BLOOD PROCESSOR CBP-6000 &?

The FDA product code for CONTINUOUS BLOOD PROCESSOR CBP-6000 & is KDI.

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Other records listing Bentley 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.

K931967HE-30 GOLDK913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000QK894826UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLFK874867CATR(TM)-H CARDIOTOMY HOLDER

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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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