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FDA 510(k)

GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL

K-Number: K820769 · 1982-04-16

ApplicantGambro, Inc.
Decision Date1982-04-16
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1982-04-16 under 510(k) number K820769. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL?

GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL is a medical device that received FDA 510(k) clearance on 1982-04-16. The listed applicant is Gambro, Inc.. The 510(k) number is K820769.

When did GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL receive FDA 510(k) clearance?

GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL received FDA 510(k) clearance on 1982-04-16, under 510(k) number K820769.

Who is the listed applicant for GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL?

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 LUNDIA 10 3N PARALLEL FLOW DIAL?

The FDA product code for GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL is FKQ.

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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: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, 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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