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FDA 510(k)

GAMBRO HEMOFREEZE-BAG

K-Number: K801082 · 1980-10-31

ApplicantGambro, Inc.
Decision Date1980-10-31
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GAMBRO HEMOFREEZE-BAG is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K801082. The device is classified under product code KSR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO HEMOFREEZE-BAG?

GAMBRO HEMOFREEZE-BAG is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is Gambro, Inc.. The 510(k) number is K801082.

When did GAMBRO HEMOFREEZE-BAG receive FDA 510(k) clearance?

GAMBRO HEMOFREEZE-BAG received FDA 510(k) clearance on 1980-10-31, under 510(k) number K801082.

Who is the listed applicant for GAMBRO HEMOFREEZE-BAG?

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 HEMOFREEZE-BAG?

The FDA product code for GAMBRO HEMOFREEZE-BAG is KSR.

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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: KSR)

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.

K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco HealthcareK020753DEROYAL SURGICAL, UMBILICUPDeroyalK810897ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.K810500BLOOD FREEZING BAGDelmed, Inc.K811523PLASMA FLEXTerumo America, Inc.K811449HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.

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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