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FDA 510(k)

GAMBRO AK-10-UDM-10-A ULTRADIFFUSION

K-Number: K800425 · 1980-04-08

ApplicantGambro, Inc.
Decision Date1980-04-08
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO AK-10-UDM-10-A ULTRADIFFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800425. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO AK-10-UDM-10-A ULTRADIFFUSION?

GAMBRO AK-10-UDM-10-A ULTRADIFFUSION is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Gambro, Inc.. The 510(k) number is K800425.

When did GAMBRO AK-10-UDM-10-A ULTRADIFFUSION receive FDA 510(k) clearance?

GAMBRO AK-10-UDM-10-A ULTRADIFFUSION received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800425.

Who is the listed applicant for GAMBRO AK-10-UDM-10-A ULTRADIFFUSION?

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

What is the FDA product code for GAMBRO AK-10-UDM-10-A ULTRADIFFUSION?

The FDA product code for GAMBRO AK-10-UDM-10-A ULTRADIFFUSION is FKP.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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Related Devices (Code: FKP)

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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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