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FDA 510(k)

GAMBRO G SERIES BLOOD LINE SETS FOR HEM.

K-Number: K801016 · 1980-05-30

ApplicantGambro, Inc.
Decision Date1980-05-30
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO G SERIES BLOOD LINE SETS FOR HEM. is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K801016. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO G SERIES BLOOD LINE SETS FOR HEM.?

GAMBRO G SERIES BLOOD LINE SETS FOR HEM. is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Gambro, Inc.. The 510(k) number is K801016.

When did GAMBRO G SERIES BLOOD LINE SETS FOR HEM. receive FDA 510(k) clearance?

GAMBRO G SERIES BLOOD LINE SETS FOR HEM. received FDA 510(k) clearance on 1980-05-30, under 510(k) number K801016.

Who is the listed applicant for GAMBRO G SERIES BLOOD LINE SETS FOR HEM.?

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 G SERIES BLOOD LINE SETS FOR HEM.?

The FDA product code for GAMBRO G SERIES BLOOD LINE SETS FOR HEM. is FJK.

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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: FJK)

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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