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FDA 510(k)

LUNDIA 10-2-N PARALLEL FLOW DIALYZER

K-Number: K830905 · 1983-04-06

ApplicantGambro, Inc.
Decision Date1983-04-06
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUNDIA 10-2-N PARALLEL FLOW DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830905. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNDIA 10-2-N PARALLEL FLOW DIALYZER?

LUNDIA 10-2-N PARALLEL FLOW DIALYZER is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Gambro, Inc.. The 510(k) number is K830905.

When did LUNDIA 10-2-N PARALLEL FLOW DIALYZER receive FDA 510(k) clearance?

LUNDIA 10-2-N PARALLEL FLOW DIALYZER received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830905.

Who is the listed applicant for LUNDIA 10-2-N PARALLEL FLOW DIALYZER?

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 LUNDIA 10-2-N PARALLEL FLOW DIALYZER?

The FDA product code for LUNDIA 10-2-N PARALLEL FLOW DIALYZER is KOC.

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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: KOC)

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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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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