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FDA 510(k)

GAMBRO FLUID CONTROL MONITOR FCM 10-1

K-Number: K864094 · 1986-11-07

ApplicantGambro, Inc.
Decision Date1986-11-07
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO FLUID CONTROL MONITOR FCM 10-1 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1986-11-07 under 510(k) number K864094. 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 FLUID CONTROL MONITOR FCM 10-1?

GAMBRO FLUID CONTROL MONITOR FCM 10-1 is a medical device that received FDA 510(k) clearance on 1986-11-07. The listed applicant is Gambro, Inc.. The 510(k) number is K864094.

When did GAMBRO FLUID CONTROL MONITOR FCM 10-1 receive FDA 510(k) clearance?

GAMBRO FLUID CONTROL MONITOR FCM 10-1 received FDA 510(k) clearance on 1986-11-07, under 510(k) number K864094.

Who is the listed applicant for GAMBRO FLUID CONTROL MONITOR FCM 10-1?

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 FLUID CONTROL MONITOR FCM 10-1?

The FDA product code for GAMBRO FLUID CONTROL MONITOR FCM 10-1 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.

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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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