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FDA 510(k)

GAMBRO BICART SYSTEM

K-Number: K873155 · 1987-10-26

ApplicantGambro, Inc.
Decision Date1987-10-26
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO BICART SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1987-10-26 under 510(k) number K873155. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO BICART SYSTEM?

GAMBRO BICART SYSTEM is a medical device that received FDA 510(k) clearance on 1987-10-26. The listed applicant is Gambro, Inc.. The 510(k) number is K873155.

When did GAMBRO BICART SYSTEM receive FDA 510(k) clearance?

GAMBRO BICART SYSTEM received FDA 510(k) clearance on 1987-10-26, under 510(k) number K873155.

Who is the listed applicant for GAMBRO BICART SYSTEM?

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 BICART SYSTEM?

The FDA product code for GAMBRO BICART SYSTEM is FKP.

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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: FKP)

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.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test 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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