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FDA 510(k)

FIBER HEMOFILTERS FH55-FH77 & 88

K-Number: K840720 · 1984-04-24

ApplicantGambro, Inc.
Decision Date1984-04-24
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBER HEMOFILTERS FH55-FH77 & 88 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K840720. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBER HEMOFILTERS FH55-FH77 & 88?

FIBER HEMOFILTERS FH55-FH77 & 88 is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Gambro, Inc.. The 510(k) number is K840720.

When did FIBER HEMOFILTERS FH55-FH77 & 88 receive FDA 510(k) clearance?

FIBER HEMOFILTERS FH55-FH77 & 88 received FDA 510(k) clearance on 1984-04-24, under 510(k) number K840720.

Who is the listed applicant for FIBER HEMOFILTERS FH55-FH77 & 88?

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 FIBER HEMOFILTERS FH55-FH77 & 88?

The FDA product code for FIBER HEMOFILTERS FH55-FH77 & 88 is KOJ.

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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: KOJ)

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.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, 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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